A Phase 2 interventional study of Tazemetostat in Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma, sponsored by Eisai Co., Ltd.. Completed at 28 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-12-16.
Sponsored by Eisai Co., Ltd. · Phase 2, Interventional, and Treatment
This is a multicenter, open-label, Phase 2 study to assess the efficacy and safety of tazemetostat in participants with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) with EZH2 gene mutation.
Eisai Co., Ltd. is the lead sponsor of 152 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with histological diagnosis of B-cell non-Hodgkin's lymphoma (NHL) as follows:
Exclusion Criteria:
Participants with significant cardiovascular impairment
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with follicular lymphoma (FL) with the EZH2 gene mutation will receive oral tazemetostat at a starting dose of 800 milligrams (mg) twice daily (1600 mg total daily dose) by continuous regimen, no less than 8 hours between doses.
Drug: Tazemetostat
Participants with diffuse large B-cell lymphoma (DLBCL) with the EZH2 gene mutation will receive oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) by continuous regimen, no less than 8 hours between doses.
Drug: Tazemetostat
Tazemetostat will be provided as a 200 mg oral tablet.
Objective Response Rate (ORR) Based on Independent Reviewer Assessment
ORR was defined as percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using independent reviewer assessment based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (\<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in sum of diameters (SOD) of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% confidence interval (CI) was calculated by Clopper-Pearson method.
Time frame: From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)
ORR Based on Investigator Assessment
ORR was defined as percentage of participants with confirmed BOR of CR or PR using investigator assessment based on RECIST 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis \<10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% CI was calculated by Clopper-Pearson method.
Time frame: From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)
Progression-free Survival (PFS) Based on Independent Reviewer Assessment
PFS was assessed by independent reviewer assessment based on RECIST 1.1. PFS was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD or death, whichever occurred first. PD for target lesion, a minimum 20% increase and a minimum 5 mm absolute increase in SOD compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir: Lowest measure SOD of target lesion at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
Time frame: From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)
PFS Based on Investigator Assessment
PFS was assessed by investigator assessment based on RECIST 1.1. PFS was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD or death, whichever occurred first. PD for target lesion, a minimum 20% increase and a minimum 5 mm absolute increase in SOD compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir: Lowest measure SOD of target lesion at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
Time frame: From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months)
Duration of Response (DOR) Based on Independent Reviewer Assessment
DOR: time from date of confirmation of the first response and the date of confirmation of the PD using independent reviewer assessment as per RECIST 1.1. BOR of CR and PR was confirmed by subsequent CR assessment and CR or PR assessment, respectively at least 4 weeks later. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes had to be reduced in short axis to \<10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD, there are no unequivocal new lesions, and no progression of non-target disease. PD for target lesion, a minimum 20% increase and a minimum 5mm absolute increase in SOD compared to nadir, or PD for non-target lesions or unequivocal new lesions. Nadir: Lowest measure SOD of target lesions at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
Time frame: From the date of first confirmed objective response (OR) to PD or death due to confirmed PR or CR (up to 3 years 4 months)
DOR Based on Investigator Assessment
DOR: time from date of confirmation of the first response and the date of confirmation of the PD using independent reviewer assessment as per RECIST 1.1. BOR of CR and PR was confirmed by subsequent CR assessment and CR or PR assessment, respectively at least 4 weeks later. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes had to be reduced in short axis to \<10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD, there are no unequivocal new lesions, and no progression of non-target disease. PD for target lesion, a minimum 20% increase and a minimum 5mm absolute increase in SOD compared to nadir, or PD for non-target lesions or unequivocal new lesions. Nadir: Lowest measure SOD of target lesions at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
Time frame: From the date of first confirmed OR to PD or death due to any cause for those participants with a confirmed PR or CR (up to 3 years 4 months)
Time to Response (TTR) Based on Independent Reviewer Assessment
TTR was defined as the time from the first dose of the study drug to date of first observation of CR or PR using independent reviewer assessment based on RECIST 1.1. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to \<10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease.
Time frame: From the date of first dose until date of first observation of CR or PR (up to 3 years 4 months)
TTR Based on Investigator Assessment
TTR was defined as the time from the first dose of the study drug to date of first observation of CR or PR using investigator assessment based on RECIST 1.1. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to \<10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease.
Time frame: From the date of first dose until date of first observation of CR or PR (up to 3 years 4 months)
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAE is defined as an AE that emerged during time from the first dose of study drug to 30 days after the participant's last dose. An AE was any untoward medical occurrence in participant administered with an investigational product. An SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening; requires participant hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).
Time frame: From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
Participants took part in the study at 28 investigative sites in Japan from 09 April 2018 to 17 December 2021.
| Milestone | Participants With Follicular Lymphoma | Participants With Diffuse Large B-cell Lymphoma |
|---|---|---|
| Started | 17 | 3 |
| Completed | 0 | 0 |
| Not completed | 17 | 3 |
| Withdrew: Disease progression | 6 | 1 |
| Withdrew: Adverse event | 4 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Discontinued from study due to switch to commercial tazemetostat | 6 | 0 |
ORR was defined as percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using independent reviewer assessment based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (\<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in sum of diameters (SOD) of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% confidence interval (CI) was calculated by Clopper-Pearson method.
| percentage of participants | Participants With Follicular Lymphoma | Participants With Diffuse Large B-cell Lymphoma |
|---|---|---|
| Objective Response Rate (ORR) Based on Independent Reviewer Assessment | 76.5 (50.1 to 93.2) | 100.0 (29.2 to 100.0) |
ORR was defined as percentage of participants with confirmed BOR of CR or PR using investigator assessment based on RECIST 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis \<10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% CI was calculated by Clopper-Pearson method.
| percentage of participants | Participants With Follicular Lymphoma | Participants With Diffuse Large B-cell Lymphoma |
|---|---|---|
| ORR Based on Investigator Assessment | 70.6 (44.0 to 89.7) | 66.7 (9.4 to 99.2) |
PFS was assessed by independent reviewer assessment based on RECIST 1.1. PFS was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD or death, whichever occurred first. PD for target lesion, a minimum 20% increase and a minimum 5 mm absolute increase in SOD compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir: Lowest measure SOD of target lesion at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
| months | Participants With Follicular Lymphoma | Participants With Diffuse Large B-cell Lymphoma |
|---|---|---|
| Progression-free Survival (PFS) Based on Independent Reviewer Assessment | NA (12.9 to NA) | 15.7 (5.3 to NA) |
PFS was assessed by investigator assessment based on RECIST 1.1. PFS was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD or death, whichever occurred first. PD for target lesion, a minimum 20% increase and a minimum 5 mm absolute increase in SOD compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir: Lowest measure SOD of target lesion at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
| months | Participants With Follicular Lymphoma | Participants With Diffuse Large B-cell Lymphoma |
|---|---|---|
| PFS Based on Investigator Assessment | NA (18.4 to NA) | 26.7 (5.3 to NA) |
DOR: time from date of confirmation of the first response and the date of confirmation of the PD using independent reviewer assessment as per RECIST 1.1. BOR of CR and PR was confirmed by subsequent CR assessment and CR or PR assessment, respectively at least 4 weeks later. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes had to be reduced in short axis to \<10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD, there are no unequivocal new lesions, and no progression of non-target disease. PD for target lesion, a minimum 20% increase and a minimum 5mm absolute increase in SOD compared to nadir, or PD for non-target lesions or unequivocal new lesions. Nadir: Lowest measure SOD of target lesions at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
| months | Participants With Follicular Lymphoma | Participants With Diffuse Large B-cell Lymphoma |
|---|---|---|
| Duration of Response (DOR) Based on Independent Reviewer Assessment | NA (11.0 to NA) | 13.8 (1.6 to NA) |
DOR: time from date of confirmation of the first response and the date of confirmation of the PD using independent reviewer assessment as per RECIST 1.1. BOR of CR and PR was confirmed by subsequent CR assessment and CR or PR assessment, respectively at least 4 weeks later. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes had to be reduced in short axis to \<10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD, there are no unequivocal new lesions, and no progression of non-target disease. PD for target lesion, a minimum 20% increase and a minimum 5mm absolute increase in SOD compared to nadir, or PD for non-target lesions or unequivocal new lesions. Nadir: Lowest measure SOD of target lesions at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate.
| months | Participants With Follicular Lymphoma | Participants With Diffuse Large B-cell Lymphoma |
|---|---|---|
| DOR Based on Investigator Assessment | 35.8 (22.1 to NA) | NA (21.1 to NA) |
TTR was defined as the time from the first dose of the study drug to date of first observation of CR or PR using independent reviewer assessment based on RECIST 1.1. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to \<10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease.
| months | Participants With Follicular Lymphoma | Participants With Diffuse Large B-cell Lymphoma |
|---|---|---|
| Time to Response (TTR) Based on Independent Reviewer Assessment | 3.64 (1.8 to 10.1) | 3.70 (1.9 to 7.4) |
TTR was defined as the time from the first dose of the study drug to date of first observation of CR or PR using investigator assessment based on RECIST 1.1. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to \<10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease.
| months | Participants With Follicular Lymphoma | Participants With Diffuse Large B-cell Lymphoma |
|---|---|---|
| TTR Based on Investigator Assessment | 4.59 (1.8 to 7.5) | 5.56 (5.5 to 5.6) |
TEAE is defined as an AE that emerged during time from the first dose of study drug to 30 days after the participant's last dose. An AE was any untoward medical occurrence in participant administered with an investigational product. An SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening; requires participant hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).
| Participants | Participants With Follicular Lymphoma | Participants With Diffuse Large B-cell Lymphoma |
|---|---|---|
| TEAEs | 17 | 3 |
| SAEs | 8 | 1 |
Collected over From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With Follicular Lymphoma | 0/17 (0%) | 8/17 (47.1%) | 17/17 (100%) |
| Participants With Diffuse Large B-cell Lymphoma | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| Event | Participants With Follicular Lymphoma | Participants With Diffuse Large B-cell Lymphoma |
|---|---|---|
| Oesophageal carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/17 | 1/3 |
| Mechanical ileusGastrointestinal disorders | 1/17 | 0/3 |
| PyrexiaGeneral disorders | 1/17 | 0/3 |
| Atypical pneumoniaInfections and infestations | 1/17 | 0/3 |
| PeriodontitisInfections and infestations | 1/17 | 0/3 |
| Pneumocystis jirovecii pneumoniaInfections and infestations | 1/17 | 0/3 |
| PneumoniaInfections and infestations | 1/17 | 0/3 |
| Traumatic intracranial haemorrhageInjury, poisoning and procedural complications | 1/17 | 0/3 |
| Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/17 | 0/3 |
| Non-small cell lung cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/17 | 0/3 |
| Event | Participants With Follicular Lymphoma | Participants With Diffuse Large B-cell Lymphoma |
|---|---|---|
| DysgeusiaNervous system disorders | 9/17 | 1/3 |
| NasopharyngitisInfections and infestations | 7/17 | 1/3 |
| Hypochromic anaemiaBlood and lymphatic system disorders | 0/17 | 1/3 |
| Supraventricular tachycardiaCardiac disorders | 0/17 | 1/3 |
| Conjunctival haemorrhageEye disorders | 1/17 | 1/3 |
| FatigueGeneral disorders | 1/17 | 1/3 |
| Non-cardiac chest painGeneral disorders | 0/17 | 1/3 |
| Electrocardiogram QT prolongedInvestigations | 1/17 | 1/3 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/17 | 1/3 |
| Back painMusculoskeletal and connective tissue disorders | 0/17 | 1/3 |
The safety analysis set included participants who received at least 1 administration of the study drug.
| Age, Continuous(years) | Participants With Follicular Lymphoma | Participants With Diffuse Large B-cell Lymphoma | Total |
|---|---|---|---|
| Mean | 65.8 ± 9.28 | 74.7 ± 7.23 | 67.1 ± 9.41 |
| Sex: Female, Male(Participants) | Participants With Follicular Lymphoma | Participants With Diffuse Large B-cell Lymphoma | Total |
|---|---|---|---|
| Female | 9 | 2 | 11 |
| Male | 8 | 1 | 9 |
| Ethnicity (NIH/OMB)(Participants) | Participants With Follicular Lymphoma | Participants With Diffuse Large B-cell Lymphoma | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 17 | 3 | 20 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Participants With Follicular Lymphoma | Participants With Diffuse Large B-cell Lymphoma | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 17 | 3 | 20 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Tazemetostat