Trial Outcomes & Findings for An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas (NCT NCT05011058)

Last Updated: 2025-07-28

Results Overview

Number (percentage) of patients with a best overall complete response (CR) or partial response (PR) according to the 2007 International Working Group (IWG) criteria, where CR included complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy with all lymph nodes and nodal masses having regressed on computed tomography to normal size, and PR included at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, no increase should have been observed in the size of other nodes, liver, or spleen, and splenic and hepatic nodules must have regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

102 participants

Primary outcome timeframe

Up to approximately 2 years

Results posted on

2025-07-28

Participant Flow

Patients with Epstein-Barr virus (EBV)-associated lymphoid malignancy were nonrandomly assigned to one of 7 cohorts defined in the Study Description module, except the first 20 patients with peripheral T-cell lymphoma were randomized (1:1) to receive either combination nanatinostat plus valganciclovir therapy or nanatinostat monotherapy. Up to 10 (Stage 1), up to 11 (Stage 2), and up to 120 (Expansion) patients were to be enrolled in each cohort depending on the number of responses observed.

Patients enrolled in the Peripheral T-Cell Lymphoma (Monotherapy) cohort who had stable disease at 6 weeks or disease progression at any time (confirmed by CT or MRI) were provided the option to cross over to receive combination therapy for the remainder of the study.

Participant milestones

Participant milestones
Measure	Diffuse Large B-Cell Lymphoma Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Extranodal Natural Killer/T-Cell Lymphoma Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Combination Therapy) Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Monotherapy) Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week	Hodgkin Lymphoma Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Post-Transplant Lymphoproliferative Disorders Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Human Immunodeficiency Virus-Associated Lymphomas Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Other EBV-Positive Lymphomas Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
Overall Study STARTED	9	11	38	10	8	3	3	20
Overall Study Stage 1	9	11	10	10	8	3	3	20
Overall Study Stage 2	0	0	11	0	0	0	0	0
Overall Study Expansion	0	0	17	0	0	0	0	0
Overall Study Crossover	0	0	0	5	0	0	0	0
Overall Study COMPLETED	7	11	24	10	8	2	3	15
Overall Study NOT COMPLETED	2	0	14	0	0	1	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Diffuse Large B-Cell Lymphoma Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Extranodal Natural Killer/T-Cell Lymphoma Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Combination Therapy) Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Monotherapy) Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week	Hodgkin Lymphoma Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Post-Transplant Lymphoproliferative Disorders Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Human Immunodeficiency Virus-Associated Lymphomas Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Other EBV-Positive Lymphomas Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
Overall Study Sponsor Decision	2	0	14	0	0	1	0	5

Baseline Characteristics

An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diffuse Large B-Cell Lymphoma n=9 Participants Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Extranodal Natural Killer/T-Cell Lymphoma n=11 Participants Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Combination Therapy) n=38 Participants Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Monotherapy) n=10 Participants Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week	Hodgkin Lymphoma n=8 Participants Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Post-Transplant Lymphoproliferative Disorders n=3 Participants Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Human Immunodeficiency Virus-Associated Lymphomas n=3 Participants Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Other EBV-Positive Lymphomas n=20 Participants Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Total n=102 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants	4 Participants n=4 Participants	7 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	9 Participants n=24 Participants	53 Participants n=42 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	24 Participants n=5 Participants	6 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	11 Participants n=24 Participants	49 Participants n=42 Participants
Age, Continuous	60 years n=5 Participants	53 years n=7 Participants	69 years n=5 Participants	69 years n=4 Participants	53.5 years n=21 Participants	50 years n=8 Participants	47 years n=8 Participants	64 years n=24 Participants	64 years n=42 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	19 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	6 Participants n=24 Participants	37 Participants n=42 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants	8 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	14 Participants n=24 Participants	65 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	15 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	10 Participants n=7 Participants	29 Participants n=5 Participants	8 Participants n=4 Participants	6 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	18 Participants n=24 Participants	83 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	4 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	7 Participants n=24 Participants	24 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	3 Participants n=7 Participants	29 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	11 Participants n=24 Participants	64 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	10 Participants n=42 Participants
Region of Enrollment Singapore	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	4 Participants n=42 Participants
Region of Enrollment United States	0 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	6 Participants n=24 Participants	30 Participants n=42 Participants
Region of Enrollment United Kingdom	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	3 Participants n=24 Participants	7 Participants n=42 Participants
Region of Enrollment Spain	1 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	13 Participants n=42 Participants
Region of Enrollment Canada	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	6 Participants n=42 Participants
Region of Enrollment South Korea	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Region of Enrollment Taiwan	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	3 Participants n=24 Participants	12 Participants n=42 Participants
Region of Enrollment Brazil	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	5 Participants n=42 Participants
Region of Enrollment Italy	3 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	4 Participants n=24 Participants	14 Participants n=42 Participants
Region of Enrollment Israel	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants
Region of Enrollment Australia	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Region of Enrollment France	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	6 Participants n=42 Participants
Region of Enrollment Germany	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants

PRIMARY outcome

Timeframe: Up to approximately 2 years

Population: Intent-to-Treat Analysis Set, defined as all patients who were enrolled into the trial regardless of whether or not they received study treatment. The study was not designed to make formal statistical comparisons of ORRs between cohorts.

Outcome measures

Outcome measures
Measure	Diffuse Large B-Cell Lymphoma n=9 Participants Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Extranodal Natural Killer/T-Cell Lymphoma n=11 Participants Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Combination Therapy) n=38 Participants Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Monotherapy) n=10 Participants Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week	Hodgkin Lymphoma n=8 Participants Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Post-Transplant Lymphoproliferative Disorders n=3 Participants Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Human Immunodeficiency Virus-Associated Lymphomas n=3 Participants Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Other EBV-Positive Lymphomas n=20 Participants Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
Objective Response Rate (ORR)	0 Participants	0 Participants	11 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to approximately 2 years

Population: Patients who achieved a CR or PR. The study was not designed to make formal statistical comparisons of DOR between cohorts.

Interval of time from date of first observed complete or partial response per 2007 International Working Group (IWG) criteria to the date of documented disease progression or death due to any cause, where disease progression is defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir. DOR was censored at the time of study withdrawal for hematopoietic stem cell transplant, or at the time of study termination, whichever was earlier, for patients whose disease was still in response.

Outcome measures

Outcome measures
Measure	Diffuse Large B-Cell Lymphoma Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Extranodal Natural Killer/T-Cell Lymphoma Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Combination Therapy) n=11 Participants Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Monotherapy) n=1 Participants Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week	Hodgkin Lymphoma Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Post-Transplant Lymphoproliferative Disorders Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Human Immunodeficiency Virus-Associated Lymphomas Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Other EBV-Positive Lymphomas n=2 Participants Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
Duration of Response (DOR)	—	—	98 days Interval 29.0 to 340.0	43 days Interval 43.0 to 43.0	—	—	—	163.5 days Interval 86.0 to 241.0

SECONDARY outcome

Timeframe: Up to approximately 3 years

Population: The clinical trial was terminated before the outcome measure data were collected (data export from the clinical database just prior to study termination retrieved from data manager files contained data listings to support determinations of other secondary efficacy outcome measures but not post-treatment anticancer therapy regimen dates to support TTNLT determination, and investigation into the cause of these uncollected data was preempted by sponsor company closure soon after study termination).

Interval of time from the start of study drug treatment to the date of next anti-lymphoma treatment (including chemotherapy, radiotherapy, radioimmunotherapy, or immunotherapy).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 3 years

Interval of time from the start of study drug treatment to the date of disease progression, where disease progression is defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir. TTP was censored at the time of study withdrawal for hematopoietic stem cell transplant, at the time of study treatment withdrawal (or at the time of crossover from monotherapy to combination therapy), or at the time of study termination, whichever was earliest, for patients without reported disease progression.

Outcome measures

Outcome measures
Measure	Diffuse Large B-Cell Lymphoma n=9 Participants Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Extranodal Natural Killer/T-Cell Lymphoma n=11 Participants Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Combination Therapy) n=38 Participants Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Monotherapy) n=10 Participants Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week	Hodgkin Lymphoma n=8 Participants Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Post-Transplant Lymphoproliferative Disorders n=3 Participants Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Human Immunodeficiency Virus-Associated Lymphomas n=3 Participants Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Other EBV-Positive Lymphomas n=20 Participants Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
Time to Progression (TTP)	81 days Interval 29.0 to 165.0	100 days Interval 23.0 to 260.0	124 days Interval 14.0 to 410.0	95 days Interval 32.0 to 136.0	77.5 days Interval 64.0 to 127.0	79 days Interval 36.0 to 351.0	108 days Interval 64.0 to 282.0	95.5 days Interval 35.0 to 311.0

SECONDARY outcome

Timeframe: Up to approximately 3 years

Interval of time from the start of study drug treatment to the date of first documented disease progression (defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir), initiation of new antineoplastic therapy, or death from any cause, whichever occurred first. PFS was censored at the time of study withdrawal for hematopoietic stem cell transplant, at the time of study treatment withdrawal (or at the time of crossover from monotherapy to combination therapy), or at the time of study termination, whichever was earliest, for patients without reported disease progression or death.

Outcome measures

Outcome measures
Measure	Diffuse Large B-Cell Lymphoma n=9 Participants Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Extranodal Natural Killer/T-Cell Lymphoma n=11 Participants Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Combination Therapy) n=38 Participants Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Monotherapy) n=10 Participants Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week	Hodgkin Lymphoma n=8 Participants Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Post-Transplant Lymphoproliferative Disorders n=3 Participants Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Human Immunodeficiency Virus-Associated Lymphomas n=3 Participants Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Other EBV-Positive Lymphomas n=20 Participants Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
Progression-Free Survival (PFS)	81 days Interval 29.0 to 165.0	110 days Interval 23.0 to 517.0	124 days Interval 14.0 to 410.0	95 days Interval 32.0 to 171.0	82 days Interval 64.0 to 313.0	79 days Interval 36.0 to 351.0	108 days Interval 64.0 to 282.0	95.5 days Interval 35.0 to 311.0

SECONDARY outcome

Timeframe: Up to approximately 3 years

Interval of time from the start of study drug treatment to the date of death for any reason. OS was censored at the time of study withdrawal or study termination, whichever was earlier, for patients without reported death.

Outcome measures

Outcome measures
Measure	Diffuse Large B-Cell Lymphoma n=9 Participants Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Extranodal Natural Killer/T-Cell Lymphoma n=11 Participants Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Combination Therapy) n=38 Participants Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Monotherapy) n=10 Participants Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week	Hodgkin Lymphoma n=8 Participants Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Post-Transplant Lymphoproliferative Disorders n=3 Participants Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Human Immunodeficiency Virus-Associated Lymphomas n=3 Participants Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Other EBV-Positive Lymphomas n=20 Participants Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
Overall Survival (OS)	131 days Interval 29.0 to 242.0	243 days Interval 35.0 to 517.0	221 days Interval 14.0 to 730.0	155 days Interval 41.0 to 611.0	570.5 days Interval 64.0 to 1000.0	171 days Interval 36.0 to 351.0	108 days Interval 76.0 to 296.0	167.5 days Interval 35.0 to 513.0

SECONDARY outcome

Timeframe: Up to approximately 2 years

Population: Safety Analysis Set, defined as all enrolled patients who received at least 1 dose of study treatment. The study was not designed to make formal statistical comparisons of AE numbers (percentages) between cohorts.

Number (percentage) of patients experiencing at least one treatment-emergent adverse event, defined as those untoward medical events with onset after the first dose of study drug or existing events that worsened after the first dose during the study

Outcome measures

Outcome measures
Measure	Diffuse Large B-Cell Lymphoma n=9 Participants Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Extranodal Natural Killer/T-Cell Lymphoma n=11 Participants Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Combination Therapy) n=38 Participants Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Monotherapy) n=10 Participants Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week	Hodgkin Lymphoma n=8 Participants Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Post-Transplant Lymphoproliferative Disorders n=3 Participants Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Human Immunodeficiency Virus-Associated Lymphomas n=3 Participants Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Other EBV-Positive Lymphomas n=20 Participants Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
Number (Percentage) of Participants With Adverse Events (AEs)	9 Participants	10 Participants	32 Participants	10 Participants	7 Participants	3 Participants	3 Participants	17 Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)

Population: Defined as all patients (pts) who received at least 1 dose of study drug on Cycle 1 Day 1 and had at least 1 valid PK concentration. Tmax data were previously generated for subset of 50 pts, 4 of whom reached Cycle 6 at time of analysis. As prespecified by the analysis plan, combination therapy cohorts were combined since Tmax for small molecules should not be affected by lymphoma subtype. PK samples from remaining pts were not tested due to sponsor company closure soon after study termination.

Defined as the time required to reach peak plasma concentration \[Cmax\] after study drug administration

Outcome measures

Outcome measures
Measure	Diffuse Large B-Cell Lymphoma n=40 Participants Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Extranodal Natural Killer/T-Cell Lymphoma n=10 Participants Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Combination Therapy) Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Monotherapy) Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week	Hodgkin Lymphoma Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Post-Transplant Lymphoproliferative Disorders Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Human Immunodeficiency Virus-Associated Lymphomas Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Other EBV-Positive Lymphomas Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
Pharmacokinetic (PK) Parameter - Time to Maximum Plasma Concentration [Tmax] Nanatinostat (Cycle 1 Day 1)	2 hours Interval 1.0 to 6.0	2 hours Interval 1.0 to 4.0	—	—	—	—	—	—
Pharmacokinetic (PK) Parameter - Time to Maximum Plasma Concentration [Tmax] Nanatinostat (Cycle 6 Day 1)	2 hours Interval 1.0 to 6.0	—	—	—	—	—	—	—
Pharmacokinetic (PK) Parameter - Time to Maximum Plasma Concentration [Tmax] M1 Metabolite (Cycle 1 Day 1)	6 hours Interval 2.0 to 6.0	5 hours Interval 2.0 to 6.0	—	—	—	—	—	—
Pharmacokinetic (PK) Parameter - Time to Maximum Plasma Concentration [Tmax] M1 Metabolite (Cycle 6 Day 1)	5 hours Interval 2.0 to 6.0	—	—	—	—	—	—	—
Pharmacokinetic (PK) Parameter - Time to Maximum Plasma Concentration [Tmax] M2 Metabolite (Cycle 1 Day 1)	4 hours Interval 1.0 to 6.0	2 hours Interval 1.0 to 6.0	—	—	—	—	—	—
Pharmacokinetic (PK) Parameter - Time to Maximum Plasma Concentration [Tmax] M2 Metabolite (Cycle 6 Day 1)	4 hours Interval 1.0 to 6.0	—	—	—	—	—	—	—
Pharmacokinetic (PK) Parameter - Time to Maximum Plasma Concentration [Tmax] Ganciclovir (Cycle 1 Day 1)	2 hours Interval 1.0 to 6.0	—	—	—	—	—	—	—
Pharmacokinetic (PK) Parameter - Time to Maximum Plasma Concentration [Tmax] Ganciclovir (Cycle 6 Day 1)	2 hours Interval 2.0 to 2.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)

Population: Defined as all patients (pts) who received at least 1 dose of study drug on Cycle 1 Day 1 and had at least 1 valid PK concentration. Cmax data were previously generated for subset of 50 pts, 4 of whom reached Cycle 6 at time of analysis. As prespecified by the analysis plan, combination therapy cohorts were combined since Cmax for small molecules should not be affected by lymphoma subtype. PK samples from remaining pts were not tested due to sponsor company closure soon after study termination.

Defined as the peak plasma concentration \[Cmax\] after study drug administration

Outcome measures

Outcome measures
Measure	Diffuse Large B-Cell Lymphoma n=40 Participants Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Extranodal Natural Killer/T-Cell Lymphoma n=10 Participants Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Combination Therapy) Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Monotherapy) Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week	Hodgkin Lymphoma Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Post-Transplant Lymphoproliferative Disorders Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Human Immunodeficiency Virus-Associated Lymphomas Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Other EBV-Positive Lymphomas Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
Pharmacokinetic (PK) Parameter - Maximum Plasma Concentration [Cmax] Nanatinostat (Cycle 1 Day 1)	116 ng/mL Geometric Coefficient of Variation 68.9	105 ng/mL Geometric Coefficient of Variation 83.0	—	—	—	—	—	—
Pharmacokinetic (PK) Parameter - Maximum Plasma Concentration [Cmax] Nanatinostat (Cycle 6 Day 1)	134 ng/mL Geometric Coefficient of Variation 121.3	—	—	—	—	—	—	—
Pharmacokinetic (PK) Parameter - Maximum Plasma Concentration [Cmax] M1 Metabolite (Cycle 1 Day 1)	435 ng/mL Geometric Coefficient of Variation 49.6	393 ng/mL Geometric Coefficient of Variation 48.3	—	—	—	—	—	—
Pharmacokinetic (PK) Parameter - Maximum Plasma Concentration [Cmax] M1 Metabolite (Cycle 6 Day 1)	427 ng/mL Geometric Coefficient of Variation 64.6	—	—	—	—	—	—	—
Pharmacokinetic (PK) Parameter - Maximum Plasma Concentration [Cmax] M2 Metabolite (Cycle 1 Day 1)	75.1 ng/mL Geometric Coefficient of Variation 56.5	65.8 ng/mL Geometric Coefficient of Variation 64.3	—	—	—	—	—	—
Pharmacokinetic (PK) Parameter - Maximum Plasma Concentration [Cmax] M2 Metabolite (Cycle 6 Day 1)	82.8 ng/mL Geometric Coefficient of Variation 79.0	—	—	—	—	—	—	—
Pharmacokinetic (PK) Parameter - Maximum Plasma Concentration [Cmax] Ganciclovir (Cycle 1 Day 1)	6350 ng/mL Geometric Coefficient of Variation 35.7	—	—	—	—	—	—	—
Pharmacokinetic (PK) Parameter - Maximum Plasma Concentration [Cmax] Ganciclovir (Cycle 6 Day 1)	5390 ng/mL Geometric Coefficient of Variation 59.6	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)

Population: Defined as all patients (pts) who received at least 1 dose of study drug on Cycle 1 Day 1 and had at least 1 valid PK concentration. AUC0-t data were previously generated for subset of 50 pts, 4 of whom reached Cycle 6 at time of analysis. As prespecified by the analysis plan, combination therapy cohorts were combined since AUC for small molecules should not be affected by lymphoma subtype. PK samples from remaining pts were not tested due to sponsor company closure soon after study termination.

Defined as the area under the concentration-time curve from time 0 to the last measurable plasma concentration

Outcome measures

Outcome measures
Measure	Diffuse Large B-Cell Lymphoma n=40 Participants Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Extranodal Natural Killer/T-Cell Lymphoma n=10 Participants Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Combination Therapy) Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Monotherapy) Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week	Hodgkin Lymphoma Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Post-Transplant Lymphoproliferative Disorders Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Human Immunodeficiency Virus-Associated Lymphomas Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Other EBV-Positive Lymphomas Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
Pharmacokinetic Parameter - Area Under the Plasma Concentration-Time Curve [AUC0-t] Nanatinostat (Cycle 1 Day 1)	284 ng*h/mL Geometric Coefficient of Variation 46.9	241 ng*h/mL Geometric Coefficient of Variation 59.3	—	—	—	—	—	—
Pharmacokinetic Parameter - Area Under the Plasma Concentration-Time Curve [AUC0-t] Nanatinostat (Cycle 6 Day 1)	291 ng*h/mL Geometric Coefficient of Variation 101.2	—	—	—	—	—	—	—
Pharmacokinetic Parameter - Area Under the Plasma Concentration-Time Curve [AUC0-t] M1 Metabolite (Cycle 1 Day 1)	1470 ng*h/mL Geometric Coefficient of Variation 70.6	1410 ng*h/mL Geometric Coefficient of Variation 56.8	—	—	—	—	—	—
Pharmacokinetic Parameter - Area Under the Plasma Concentration-Time Curve [AUC0-t] M1 Metabolite (Cycle 6 Day 1)	3750 ng*h/mL Geometric Coefficient of Variation 42.2	—	—	—	—	—	—	—
Pharmacokinetic Parameter - Area Under the Plasma Concentration-Time Curve [AUC0-t] M2 Metabolite (Cycle 1 Day 1)	263 ng*h/mL Geometric Coefficient of Variation 71.9	248 ng*h/mL Geometric Coefficient of Variation 66.2	—	—	—	—	—	—
Pharmacokinetic Parameter - Area Under the Plasma Concentration-Time Curve [AUC0-t] M2 Metabolite (Cycle 6 Day 1)	335 ng*h/mL Geometric Coefficient of Variation 168.2	—	—	—	—	—	—	—
Pharmacokinetic Parameter - Area Under the Plasma Concentration-Time Curve [AUC0-t] Ganciclovir (Cycle 1 Day 1)	21600 ng*h/mL Geometric Coefficient of Variation 34.9	—	—	—	—	—	—	—
Pharmacokinetic Parameter - Area Under the Plasma Concentration-Time Curve [AUC0-t] Ganciclovir (Cycle 6 Day 1)	33400 ng*h/mL Geometric Coefficient of Variation 20.4	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)

Population: Defined as all patients who received at least 1 dose of study drug on Cycle 1 Day 1 and had at least 2 valid PK concentrations in the terminal elimination phase. This stricter requirement explains why, for example, the overall number analyzed for t1/2 (ie, 16) is less than the overall number analyzed for the other PK parameters (ie, 50). As prespecified by the analysis plan, combination therapy cohorts were combined since t1/2 for small molecules should not be affected by lymphoma subtype.

Defined as the time required to reduce plasma concentration by 50% after study drug administration

Outcome measures

Outcome measures
Measure	Diffuse Large B-Cell Lymphoma n=12 Participants Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Extranodal Natural Killer/T-Cell Lymphoma n=4 Participants Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Combination Therapy) Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Monotherapy) Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week	Hodgkin Lymphoma Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Post-Transplant Lymphoproliferative Disorders Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Human Immunodeficiency Virus-Associated Lymphomas Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Other EBV-Positive Lymphomas Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
Pharmacokinetic (PK) Parameter - Half-Life [t1/2] Nanatinostat (Cycle 6 Day 1)	1.21 hours Standard Deviation 0	—	—	—	—	—	—	—
Pharmacokinetic (PK) Parameter - Half-Life [t1/2] Nanatinostat (Cycle 1 Day 1)	1.52 hours Standard Deviation 0.464	2.17 hours Standard Deviation 0.503	—	—	—	—	—	—
Pharmacokinetic (PK) Parameter - Half-Life [t1/2] Ganciclovir (Cycle 1 Day 1)	3.41 hours Standard Deviation 1.34	—	—	—	—	—	—	—
Pharmacokinetic (PK) Parameter - Half-Life [t1/2] Ganciclovir (Cycle 6 Day 1)	5.31 hours Standard Deviation 2.36	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to approximately 2 years

Population: Intent-to-Treat Analysis Set, defined as all patients who were enrolled into the trial regardless of whether or not they received study treatment. The sum of the Overall Number of Participants Analyzed across all subgroups (ie, 57) additionally includes pre-specified ORR analyses in a subset of 14 patients in the Peripheral T-Cell Lymphoma (Combination Therapy) cohort previously treated with only 1 line of anti-lymphoma therapy.

Outcome measures

Outcome measures
Measure	Diffuse Large B-Cell Lymphoma n=10 Participants Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Extranodal Natural Killer/T-Cell Lymphoma n=5 Participants Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Combination Therapy) n=11 Participants Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Monotherapy) n=4 Participants Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week	Hodgkin Lymphoma n=17 Participants Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Post-Transplant Lymphoproliferative Disorders n=5 Participants Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Human Immunodeficiency Virus-Associated Lymphomas n=5 Participants Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Other EBV-Positive Lymphomas Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
Objective Response Rate (ORR) by Study Milestone in the Peripheral T-Cell Lymphoma (Combination Therapy) Cohort That Enrolled Patients Beyond Stage 1 or in the Peripheral T-Cell Lymphoma (Monotherapy) Cohort Who Crossed Over to Receive Combination Therapy	5 Participants	5 Participants	2 Participants	1 Participants	4 Participants	1 Participants	2 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to approximately 2 years

Population: Patients who achieved a CR or PR

Outcome measures

Outcome measures
Measure	Diffuse Large B-Cell Lymphoma n=5 Participants Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Extranodal Natural Killer/T-Cell Lymphoma n=5 Participants Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Combination Therapy) n=2 Participants Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Monotherapy) n=1 Participants Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week	Hodgkin Lymphoma n=4 Participants Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Post-Transplant Lymphoproliferative Disorders n=1 Participants Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Human Immunodeficiency Virus-Associated Lymphomas n=2 Participants Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Other EBV-Positive Lymphomas Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
Duration of Response (DOR) by Study Milestone in the Peripheral T-Cell Lymphoma (Combination Therapy) Cohort That Enrolled Patients Beyond Stage 1 or in the Peripheral T-Cell Lymphoma (Monotherapy) Cohort Who Crossed Over to Receive Combination Therapy	86 days Interval 36.0 to 340.0	86 days Interval 36.0 to 340.0	125 days Interval 29.0 to 221.0	29 days Interval 29.0 to 29.0	99 days Interval 73.0 to 126.0	73 days Interval 73.0 to 73.0	192 days Interval 79.0 to 305.0	—

Adverse Events

Diffuse Large B-Cell Lymphoma

Serious events: 3 serious events

Other events: 9 other events

Deaths: 3 deaths

Extranodal Natural Killer/T-Cell Lymphoma

Serious events: 7 serious events

Other events: 10 other events

Deaths: 9 deaths

Peripheral T-Cell Lymphoma (Combination Therapy)

Serious events: 9 serious events

Other events: 32 other events

Deaths: 9 deaths

Peripheral T-Cell Lymphoma (Monotherapy)

Serious events: 5 serious events

Other events: 10 other events

Deaths: 4 deaths

Peripheral T-Cell Lymphoma (Crossover)

Serious events: 3 serious events

Other events: 5 other events

Deaths: 2 deaths

Hodgkin Lymphoma

Serious events: 2 serious events

Other events: 7 other events

Deaths: 3 deaths

Post-Transplant Lymphoproliferative Disorders

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Human Immunodeficiency Virus-Associated Lymphomas

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Other EBV-Positive Lymphomas

Serious events: 10 serious events

Other events: 17 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Diffuse Large B-Cell Lymphoma n=9 participants at risk Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Extranodal Natural Killer/T-Cell Lymphoma n=11 participants at risk Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Combination Therapy) n=38 participants at risk Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Monotherapy) n=10 participants at risk Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week	Peripheral T-Cell Lymphoma (Crossover) n=5 participants at risk Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD after having been treated with nanatinostat 20 mg QD on Days 1 to 4 per week without response in the monotherapy cohort	Hodgkin Lymphoma n=8 participants at risk Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Post-Transplant Lymphoproliferative Disorders n=3 participants at risk Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Human Immunodeficiency Virus-Associated Lymphomas n=3 participants at risk Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Other EBV-Positive Lymphomas n=20 participants at risk Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
Infections and infestations Pneumonia	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.3% 2/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 1/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 4/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations Sepsis	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	2.6% 1/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 1/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations Septic shock	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations Upper respiratory tract infection	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	2.6% 1/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	12.5% 1/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations Urinary tract infection	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.3% 2/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations Abdominal infection	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations COVID-19	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations Escherichia infection	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations H1N1 influenza	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations Influenza	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	2.6% 1/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations Lymph gland infection	11.1% 1/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations Pharyngitis	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 1/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations Pneumonia aspiration	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations Pneumonia haemophilus	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	12.5% 1/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations Soft tissue infection	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
General disorders Pyrexia	11.1% 1/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	27.3% 3/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	2.6% 1/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 2/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
General disorders General physical health deterioration	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	2.6% 1/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations Swelling face	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Blood and lymphatic system disorders Anaemia	11.1% 1/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 2/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	2.6% 1/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Blood and lymphatic system disorders Pancytopenia	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	2.6% 1/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Abdominal pain	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Dysphagia	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Faecaloma	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Impaired gastric emptying	11.1% 1/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Oesophagitis	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Pancreatitis	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Pancreatitis acute	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	12.5% 1/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Vomiting	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.3% 2/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Pharyngeal haemorrhage	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Pneumonitis aspiration	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Musculoskeletal and connective tissue disorders Muscular weakness	11.1% 1/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Investigations Platelet count decreased	11.1% 1/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	2.6% 1/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Investigations Neutrophil count decreased	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	35.0% 7/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	2.6% 1/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Failure to thrive	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Psychiatric disorders Confusional state	11.1% 1/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	2.6% 1/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Psychiatric disorders Delirium	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Renal and urinary disorders Acute kidney injury	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	2.6% 1/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Renal and urinary disorders Hydronephrosis	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Vascular disorders Hypotension	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Vascular disorders Orthostatic hypotension	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Nervous system disorders Dizziness postural	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Nervous system disorders Loss of consciousness	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Cardiac disorders Sinus tachycardia	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events

Other adverse events

Other adverse events
Measure	Diffuse Large B-Cell Lymphoma n=9 participants at risk Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Extranodal Natural Killer/T-Cell Lymphoma n=11 participants at risk Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Combination Therapy) n=38 participants at risk Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Peripheral T-Cell Lymphoma (Monotherapy) n=10 participants at risk Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week	Peripheral T-Cell Lymphoma (Crossover) n=5 participants at risk Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD after having been treated with nanatinostat 20 mg QD on Days 1 to 4 per week without response in the monotherapy cohort	Hodgkin Lymphoma n=8 participants at risk Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Post-Transplant Lymphoproliferative Disorders n=3 participants at risk Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Human Immunodeficiency Virus-Associated Lymphomas n=3 participants at risk Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD	Other EBV-Positive Lymphomas n=20 participants at risk Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
Blood and lymphatic system disorders Anaemia	22.2% 2/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	36.4% 4/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	18.4% 7/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	50.0% 5/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	60.0% 3/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	50.0% 4/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	66.7% 2/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	35.0% 7/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Nausea	11.1% 1/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	63.6% 7/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	31.6% 12/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 1/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	50.0% 4/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	25.0% 5/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Investigations Neutrophil count decreased	33.3% 3/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	36.4% 4/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	23.7% 9/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	30.0% 3/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	60.0% 3/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	37.5% 3/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	35.0% 7/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
General disorders Fatigue	22.2% 2/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	36.4% 4/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	21.1% 8/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	40.0% 4/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	25.0% 2/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	66.7% 2/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	66.7% 2/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	35.0% 7/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
General disorders Pyrexia	22.2% 2/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	54.5% 6/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	31.6% 12/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	30.0% 3/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	12.5% 1/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 4/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Decreased appetite	11.1% 1/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	36.4% 4/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	23.7% 9/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	50.0% 5/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	37.5% 3/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	25.0% 5/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Investigations Platelet count decreased	22.2% 2/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	36.4% 4/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	21.1% 8/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	40.0% 4/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	40.0% 2/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	12.5% 1/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	15.0% 3/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Diarrhoea	22.2% 2/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	18.2% 2/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	15.8% 6/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	30.0% 3/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	37.5% 3/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	15.0% 3/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Cough	11.1% 1/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	36.4% 4/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	13.2% 5/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	37.5% 3/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 2/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Vomiting	11.1% 1/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	36.4% 4/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.5% 4/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	12.5% 1/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	15.0% 3/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Investigations White blood cell decreased	11.1% 1/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.5% 4/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 2/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	40.0% 2/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	25.0% 2/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	27.3% 3/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	13.2% 5/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 1/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	12.5% 1/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 2/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Investigations Blood creatinine increased	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	13.2% 5/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	25.0% 2/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 2/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations Pneumonia	22.2% 2/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	7.9% 3/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 1/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	15.0% 3/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
General disorders Asthenia	11.1% 1/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	7.9% 3/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 1/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	25.0% 2/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 2/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations COVID-19	11.1% 1/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	7.9% 3/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	15.0% 3/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Renal and urinary disorders Acute kidney injury	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	18.2% 2/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	7.9% 3/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	15.0% 3/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	27.3% 3/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	2.6% 1/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	40.0% 2/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	12.5% 1/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Investigations Weight decreased	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	18.2% 2/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	7.9% 3/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	12.5% 1/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 2/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.3% 2/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 1/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	12.5% 1/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 2/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	18.2% 2/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.3% 2/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 1/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	15.0% 3/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Abdominal pain	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	18.2% 2/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.3% 2/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 1/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 2/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	66.7% 2/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Gastrointestinal disorders Constipation	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	27.3% 3/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	7.9% 3/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Vascular disorders Hypotension	11.1% 1/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	18.2% 2/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	2.6% 1/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 2/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	15.8% 6/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Skin and subcutaneous tissue disorders Rash	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.5% 4/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 2/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations Upper respiratory tract infection	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.3% 2/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	37.5% 3/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.3% 2/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 1/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	7.9% 3/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	25.0% 2/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.5% 4/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events
Infections and infestations Sepsis	0.00% 0/9 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	9.1% 1/11 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	2.6% 1/38 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	10.0% 1/10 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	20.0% 1/5 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/8 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	0.00% 0/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	33.3% 1/3 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events	5.0% 1/20 • Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events

Additional Information

Dr. Darrel Cohen

Viracta Therapeutics

Phone: 858-400-8470

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60