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| ID | Type | Description | Link |
|---|---|---|---|
| H6Q-MC-S057 | Other Identifier | Eli Lilly and Company |
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In this study, all patients will get investigational drug. There will be no comparator drug. This study will evaluate three tumor types: T-cell lymphoma, Indolent B-cell lymphoma, and Aggressive B-cell lymphoma. Each tumor type will include several tumor subtypes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-Cell | Experimental | T-Cell (TCL): Peripheral and cutaneous T-cell lymphoma (PTCL, CTCL). Participants received enzastaurin 1125 milligram (mg) loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days |
|
| Indolent B-Cell | Experimental | Indolent B-Cell (IBCL): Small lymphocytic lymphoma, follicular lymphoma (Grade 1 or 2) and marginal zone lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days |
|
| Aggressive B-Cell | Experimental | Aggressive B-Cell (ABCL): Primary central nervous system (CNS) lymphoma, follicular lymphoma (Grade 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzastaurin | Drug | 1125 mg loading dose then 500 mg, oral, daily until progressive disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Tumor RR is defined as the number of responders divided by the number of treated participants for that tumor subtype. A responder was a participant who exhibited: a CR defined as a modified severity-weighted assessment tool (mSWAT) value of zero or a partial response (PR) defined as a mSWAT value > 50% decrease from baseline [for participants with cutaneous T-cell lymphoma (CTCL) using the mSWAT or CR, unconfirmed CR (Cru), or PR as defined by Abrey et al., (2005) (for participants with central nervous system (CNS) Lymphoma); or for all other participants a CR or complete response - unconfirmed (CRu) or PR as defined by Cheson et al., (1999).](streamdown:incomplete-link) | Baseline to Measured Progressive Disease (Up to 114 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Progression-free survival is defined as the time from the date of study enrollment to the first date of objectively determined progressive disease or death from any cause. Progressive disease (PD) is an increase of Sézary cell percentage by greater than or equal to 40% in cluster of differentiation (CD4+/CD7- or 30% in CD4+/CD26- as compared to each respective nadir. mSWAT, primary central nervous system lymphoma (PCSNSL) and International Workshop Response Criteria (IWRC) response criteria were used for CTCL, primary central nervous system lymphoma (CNSL) and all other participants respectively. PFS was censored at the date of the last objective progression-free assessment. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Anaheim | California | 92801 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23770158 | Derived | Forsyth CJ, Gomez-Almaguer D, Camargo JF, Eliadis PE, Crespo-Solis E, Pereira J, Gutierrez-Aguirre CH, Rivas-Vera S, Roberson S, Lin B, Smith NV, Hamid O. A multicenter, open-label, noncomparative screening study of enzastaurin in adult patients with non-Hodgkin lymphomas. Clin Lymphoma Myeloma Leuk. 2013 Aug;13(4):398-403. doi: 10.1016/j.clml.2013.03.005. Epub 2013 Jun 14. |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Completers include participants who had progressive disease, died due to any cause or alive and on study at the end of study, but off treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | T-Cell (TCL) | T-Cell (TCL): Peripheral and cutaneous T-cell lymphoma (PTCL, CTCL). Participants received enzastaurin 1125 milligram (mg) loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. |
| FG001 | Indolent B-Cell (IBCL) | Indolent B-Cell (IBCL): Small lymphocytic lymphoma, follicular lymphoma (Grade 1 or 2) and marginal zone lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. |
| FG002 | Aggressive B-Cell (ABCL) | Aggressive B-Cell (ABCL): Primary central nervous system (CNS) lymphoma, follicular lymphoma (Grade 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | T-Cell | T-Cell (TCL): Peripheral and cutaneous T-cell lymphoma (PTCL, CTCL). Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR]) | Tumor RR is defined as the number of responders divided by the number of treated participants for that tumor subtype. A responder was a participant who exhibited: a CR defined as a modified severity-weighted assessment tool (mSWAT) value of zero or a partial response (PR) defined as a mSWAT value > 50% decrease from baseline [for participants with cutaneous T-cell lymphoma (CTCL) using the mSWAT or CR, unconfirmed CR (Cru), or PR as defined by Abrey et al., (2005) (for participants with central nervous system (CNS) Lymphoma); or for all other participants a CR or complete response - unconfirmed (CRu) or PR as defined by Cheson et al., (1999).](streamdown:incomplete-link) | All participants with all tumor subtypes, who received at least one dose of study drug, and had evaluable tumor response rate data. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Measured Progressive Disease (Up to 114 Months) |
|
Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T-Cell | Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C504878 | enzastaurin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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| Baseline to Measured Progressive Disease or Death From Any Cause (Up to 114 Months) |
| Time to Progressive (TTP) Disease | TTP disease is defined as the time from the date of study enrollment to the date of objectively determined disease progression. Objectively determined progressive disease (PD) was interpreted as meeting the criteria for PD. For patients who died without documented objective PD (including death from study disease); TTP was censored at the date of the last objective progression-free disease assessment prior to death. For participants not known to have died as of the data cut-off date and who did not have objective PD, TTP was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent anticancer therapy (after discontinuation from study treatment) prior to objectively determined disease progression, TTP was censored at the date of the last objective progression free disease assessment prior to post-discontinuation therapy. | Baseline to Measured Progressive Disease (Up to 114 Months) |
| Duration of Response (DOR) | DoR is defined as the time from the date when the measurement criteria were met for CR, CRu, or PR (whichever status was recorded first) until the date of first observation of objectively determined disease progression (CR, CRu, or PR see above definition of responder). For responding participants who died without PD (including death from study disease), DoR was censored at the last assessment demonstrating lack of progression. For responding patients not known to have died as of the data cut-off date and who did not have PD, DoR was censored at the last assessment demonstrating objective response prior to the data cut-off date. For responding participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression, DoR was censored at the last assessment demonstrating objective response prior to the initiation of post-discontinuation anticancer therapy. | Baseline to Measured Progressive Disease (Up to 97 Months) |
| Percentage of Participants With Progression Free Survival (PFS) at 1-Year | PFS at 1 year was defined as the probability of being alive and having not progressed at 1 year and calculated from the PFS Kaplan-Meier analysis. PFS was censored at the date of the last objective progression-free assessment. Progressive disease (PD) is an increase of Sézary cell percentage by greater than or equal to 40% in cluster of differentiation (CD4+/CD7- or 30% in CD4+/CD26- as compared to each respective nadir. mSWAT, primary central nervous system lymphoma (PCSNSL) and International Workshop Response Criteria (IWRC) response criteria were used for CTCL, primary central nervous system lymphoma (CNSL) and all other participants respectively. PFS was censored at the date of the last objective progression-free assessment. | Baseline to Measured Progressive Disease or Death From Any Cause (1 Year) |
| Number of Participants With One or More Drug-Related Adverse Events | Number of participants with one or more Drug-Related Adverse Events. Clinically significant events are defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module. | Baseline to End of Study (Up to 114 Months) |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Garran | Australian Capital Territory | 2605 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gosford | New South Wales | 2250 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Auchenflower | Queensland | 4066 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Prahran | Victoria | 3181 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | BrasÃlia | 70710-904 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Curitiba | 81520-060 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jaú | 17210-120 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Porto Alegre | 90430-090 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | São Paulo | 01323-903 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Monterrey | 64460 | Mexico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tepic | 63000 | Mexico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tlalpan | 14080 | Mexico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lima | LIMA13 | Peru |
| Physician Decision |
|
| Sponsor Decision |
|
| Lost to Follow-up |
|
| BG001 | Indolent B-Cell | Indolent B-Cell (IBCL): Small lymphocytic lymphoma, follicular lymphoma (Grade 1 or 2) and marginal zone lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. |
| BG002 | Aggressive B-Cell | Aggressive B-Cell (ABCL): Primary central nervous system (CNS) lymphoma, follicular lymphoma (Grade 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG000 |
| Peripheral T-cell Lymphoma (PTCL) |
Participants who had PTCL tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. |
| OG001 | Cutaneous T-cell Lymphoma (CTCL) | Participants who had CTCL tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. |
| OG002 | Small Lymphocytic Indolent B-Cell Lymphoma (IBCL) | Participants who had small lymphocytic IBCL tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. |
| OG003 | Follicular Grade 1 & 2 (IBCL) | Participants who had follicular grade 1 & 2 IBCL tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. |
| OG004 | Marginal Zone Lymphoma (IBCL) | Participants who had marginal zone lymphoma IBCL tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. |
| OG005 | Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL) | Participants who had follicular grade 3 a ABCL tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. |
| OG006 | History of IBCL (ABCL) | Participants who had a history of IBCL (ABCL) tumor subtype and received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. |
|
|
| Secondary | Progression Free Survival (PFS) | Progression-free survival is defined as the time from the date of study enrollment to the first date of objectively determined progressive disease or death from any cause. Progressive disease (PD) is an increase of Sézary cell percentage by greater than or equal to 40% in cluster of differentiation (CD4+/CD7- or 30% in CD4+/CD26- as compared to each respective nadir. mSWAT, primary central nervous system lymphoma (PCSNSL) and International Workshop Response Criteria (IWRC) response criteria were used for CTCL, primary central nervous system lymphoma (CNSL) and all other participants respectively. PFS was censored at the date of the last objective progression-free assessment. | All participants with all tumor subtypes, who received at least one dose of study drug and had evaluable PFS data. Participants censored: 0 (PTCL), 3 (CTCL), 0 (small lymphocytic), 2 (follicular grade 1 & 2), 0 (follicular grade 3a and 4b), 0 (marginal zone) and 4 (history of IBCL) | Posted | Median | 95% Confidence Interval | Days | Baseline to Measured Progressive Disease or Death From Any Cause (Up to 114 Months) |
|
|
|
| Secondary | Time to Progressive (TTP) Disease | TTP disease is defined as the time from the date of study enrollment to the date of objectively determined disease progression. Objectively determined progressive disease (PD) was interpreted as meeting the criteria for PD. For patients who died without documented objective PD (including death from study disease); TTP was censored at the date of the last objective progression-free disease assessment prior to death. For participants not known to have died as of the data cut-off date and who did not have objective PD, TTP was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent anticancer therapy (after discontinuation from study treatment) prior to objectively determined disease progression, TTP was censored at the date of the last objective progression free disease assessment prior to post-discontinuation therapy. | All participants with all tumor subtypes, who received at least one dose of study drug and had evaluable TTP data. Participants censored: 0 (PTCL), 3 (CTCL), 0 (small lymphocytic), 2 (follicular grade 1 & 2), 0 (follicular grade 3a and 4b), 0 (marginal zone) and 4 (history of IBCL) | Posted | Median | 95% Confidence Interval | Days | Baseline to Measured Progressive Disease (Up to 114 Months) |
|
|
|
| Secondary | Duration of Response (DOR) | DoR is defined as the time from the date when the measurement criteria were met for CR, CRu, or PR (whichever status was recorded first) until the date of first observation of objectively determined disease progression (CR, CRu, or PR see above definition of responder). For responding participants who died without PD (including death from study disease), DoR was censored at the last assessment demonstrating lack of progression. For responding patients not known to have died as of the data cut-off date and who did not have PD, DoR was censored at the last assessment demonstrating objective response prior to the data cut-off date. For responding participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression, DoR was censored at the last assessment demonstrating objective response prior to the initiation of post-discontinuation anticancer therapy. | All participants with all tumor subtypes, who received at least one dose of study drug and had evaluable DOR data. | Posted | Median | Full Range | Days | Baseline to Measured Progressive Disease (Up to 97 Months) |
|
|
|
| Secondary | Percentage of Participants With Progression Free Survival (PFS) at 1-Year | PFS at 1 year was defined as the probability of being alive and having not progressed at 1 year and calculated from the PFS Kaplan-Meier analysis. PFS was censored at the date of the last objective progression-free assessment. Progressive disease (PD) is an increase of Sézary cell percentage by greater than or equal to 40% in cluster of differentiation (CD4+/CD7- or 30% in CD4+/CD26- as compared to each respective nadir. mSWAT, primary central nervous system lymphoma (PCSNSL) and International Workshop Response Criteria (IWRC) response criteria were used for CTCL, primary central nervous system lymphoma (CNSL) and all other participants respectively. PFS was censored at the date of the last objective progression-free assessment. | All participants with all tumor subtypes, who received at least one dose of study drug and had evaluable 1-year rate PFS data. | Posted | Number | percentage of participants | Baseline to Measured Progressive Disease or Death From Any Cause (1 Year) |
|
|
|
| Secondary | Number of Participants With One or More Drug-Related Adverse Events | Number of participants with one or more Drug-Related Adverse Events. Clinically significant events are defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline to End of Study (Up to 114 Months) |
|
|
|
| 9 |
| 23 |
| 19 |
| 23 |
| EG001 | Indolent B-Cell | Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. | 11 | 19 | 17 | 19 |
| EG002 | Aggressive B-Cell | Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days. | 5 | 15 | 10 | 15 |
| Anaemia of malignant disease | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Colonic obstruction | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Hepatitis b | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Peritonitis bacterial | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Non-hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hallucinations, mixed | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pelvic venous thrombosis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Retroperitoneal lymphadenopathy | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 10.1 | Systematic Assessment |
|
| Vestibular neuronitis | Ear and labyrinth disorders | MedDRA 10.1 | Systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| Retinitis | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Gingival erythema | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Gingival oedema | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hepatic cyst | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Central nervous system infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Gastrointestinal candidiasis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Tracheobronchitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood urea decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Lymphocyte count increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Prothrombin time prolonged | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Lactose intolerance | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Tetany | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Nodal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Fibromatosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Ocular neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Pharyngeal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Ejaculation disorder | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
|
| Genital discharge | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
|
| Scrotal oedema | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
|
| Uterine polyp | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Penile ulceration | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
Not provided
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |