Trial Outcomes & Findings for A Study for Patients With Non-Hodgkin's Lymphomas (NCT NCT00542919)
NCT ID: NCT00542919
Last Updated: 2020-10-19
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Baseline to Measured Progressive Disease (Up to 114 Months)
Results posted on
2020-10-19
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
19
|
15
|
|
Overall Study
Received At Least One Dose of Study Drug
|
23
|
19
|
15
|
|
Overall Study
Progressive Disease
|
15
|
11
|
7
|
|
Overall Study
Death
|
1
|
1
|
2
|
|
Overall Study
COMPLETED
|
16
|
12
|
9
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
|
Overall Study
Physician Decision
|
2
|
2
|
1
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
Baseline Characteristics
A Study for Patients With Non-Hodgkin's Lymphomas
Baseline characteristics by cohort
| Measure |
T-Cell
n=23 Participants
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.
|
Indolent B-Cell
n=19 Participants
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
n=15 Participants
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.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 17.54 • n=5 Participants
|
69.7 years
STANDARD_DEVIATION 10.46 • n=7 Participants
|
60.1 years
STANDARD_DEVIATION 8.44 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 15.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
38 Participants
n=4 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
Peru
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Measured Progressive Disease (Up to 114 Months)Population: All participants with all tumor subtypes, who received at least one dose of study drug, and had evaluable tumor response rate data.
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).
Outcome measures
| Measure |
Peripheral T-cell Lymphoma (PTCL)
n=12 Participants
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.
|
Cutaneous T-cell Lymphoma (CTCL)
n=11 Participants
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.
|
Small Lymphocytic Indolent B-Cell Lymphoma (IBCL)
n=7 Participants
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.
|
Follicular Grade 1 & 2 (IBCL)
n=8 Participants
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.
|
Marginal Zone Lymphoma (IBCL)
n=4 Participants
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.
|
Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL)
n=5 Participants
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.
|
History of IBCL (ABCL)
n=10 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])
CR
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
10.0 percentage of participants
Interval 0.3 to 44.5
|
|
Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])
CRu
|
0 percentage of participants
Interval 0.0 to 0.0
|
9.1 percentage of participants
Interval 0.2 to 41.3
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])
PR
|
0 percentage of participants
Interval 0.0 to 0.0
|
9.1 percentage of participants
Interval 0.2 to 41.3
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
0 percentage of participants
Interval 0.0 to 0.0
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])
Stable Disease
|
33.3 percentage of participants
Interval 9.9 to 65.1
|
36.4 percentage of participants
Interval 10.9 to 69.2
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
50.0 percentage of participants
Interval 18.7 to 81.3
|
|
Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])
Progressive Disease (PD)
|
50.0 percentage of participants
Interval 21.1 to 78.9
|
36.4 percentage of participants
Interval 10.9 to 69.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
0 percentage of participants
Interval 0.0 to 0.0
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
30.0 percentage of participants
Interval 6.7 to 65.2
|
|
Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])
Unknown
|
16.7 percentage of participants
Interval 2.1 to 48.4
|
9.1 percentage of participants
Interval 0.2 to 41.3
|
0 percentage of participants
Interval 0.0 to 0.0
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
0 percentage of participants
Interval 0.0 to 0.0
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
10.0 percentage of participants
Interval 0.3 to 44.5
|
SECONDARY outcome
Timeframe: Baseline to Measured Progressive Disease or Death From Any Cause (Up to 114 Months)Population: 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)
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.
Outcome measures
| Measure |
Peripheral T-cell Lymphoma (PTCL)
n=12 Participants
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.
|
Cutaneous T-cell Lymphoma (CTCL)
n=11 Participants
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.
|
Small Lymphocytic Indolent B-Cell Lymphoma (IBCL)
n=7 Participants
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.
|
Follicular Grade 1 & 2 (IBCL)
n=8 Participants
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.
|
Marginal Zone Lymphoma (IBCL)
n=4 Participants
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.
|
Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL)
n=5 Participants
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.
|
History of IBCL (ABCL)
n=10 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
58 Days
Interval 23.0 to 95.0
|
227 Days
Interval 31.0 to 761.0
|
303 Days
Interval 113.0 to 342.0
|
429 Days
Interval 51.0 to 672.0
|
159 Days
Interval 67.0 to 168.0
|
114 Days
Interval 27.0 to 547.0
|
68 Days
Interval 11.0 to
The upper limit could not be calculated due to the small number of events.
|
SECONDARY outcome
Timeframe: Baseline to Measured Progressive Disease (Up to 114 Months)Population: 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)
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.
Outcome measures
| Measure |
Peripheral T-cell Lymphoma (PTCL)
n=12 Participants
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.
|
Cutaneous T-cell Lymphoma (CTCL)
n=11 Participants
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.
|
Small Lymphocytic Indolent B-Cell Lymphoma (IBCL)
n=7 Participants
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.
|
Follicular Grade 1 & 2 (IBCL)
n=8 Participants
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.
|
Marginal Zone Lymphoma (IBCL)
n=4 Participants
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.
|
Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL)
n=5 Participants
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.
|
History of IBCL (ABCL)
n=10 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Time to Progressive (TTP) Disease
|
58 Days
Interval 23.0 to 95.0
|
227 Days
Interval 31.0 to 761.0
|
308 Days
Interval 113.0 to 556.0
|
429 Days
Interval 51.0 to 672.0
|
159 Days
Interval 67.0 to 168.0
|
114 Days
Interval 27.0 to 547.0
|
68 Days
Interval 11.0 to
The upper limit could not be calculated due to the small number of events.
|
SECONDARY outcome
Timeframe: Baseline to Measured Progressive Disease (Up to 97 Months)Population: All participants with all tumor subtypes, who received at least one dose of study drug and had evaluable DOR data.
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.
Outcome measures
| Measure |
Peripheral T-cell Lymphoma (PTCL)
n=12 Participants
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.
|
Cutaneous T-cell Lymphoma (CTCL)
n=11 Participants
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.
|
Small Lymphocytic Indolent B-Cell Lymphoma (IBCL)
n=7 Participants
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.
|
Follicular Grade 1 & 2 (IBCL)
n=8 Participants
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.
|
Marginal Zone Lymphoma (IBCL)
n=4 Participants
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.
|
Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL)
n=5 Participants
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.
|
History of IBCL (ABCL)
n=10 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
0 Days
Interval 0.0 to 0.0
|
394.0 Days
Interval 141.0 to 647.0
|
281.0 Days
Interval 281.0 to 281.0
|
1.0 Days
Interval 1.0 to 1.0
|
0 Days
Interval 0.0 to 0.0
|
58.0 Days
Interval 58.0 to 58.0
|
2957.0 Days
Interval 2957.0 to 2957.0
|
SECONDARY outcome
Timeframe: Baseline to Measured Progressive Disease or Death From Any Cause (1 Year)Population: All participants with all tumor subtypes, who received at least one dose of study drug and had evaluable 1-year rate PFS data.
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.
Outcome measures
| Measure |
Peripheral T-cell Lymphoma (PTCL)
n=12 Participants
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.
|
Cutaneous T-cell Lymphoma (CTCL)
n=11 Participants
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.
|
Small Lymphocytic Indolent B-Cell Lymphoma (IBCL)
n=7 Participants
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.
|
Follicular Grade 1 & 2 (IBCL)
n=8 Participants
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.
|
Marginal Zone Lymphoma (IBCL)
n=4 Participants
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.
|
Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL)
n=5 Participants
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.
|
History of IBCL (ABCL)
n=10 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Progression Free Survival (PFS) at 1-Year
|
0.0 percentage of participants
|
36.8 percentage of participants
|
14.3 percentage of participants
|
51.4 percentage of participants
|
0.0 percentage of participants
|
25.0 percentage of participants
|
48.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to End of Study (Up to 114 Months)Population: All participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
Peripheral T-cell Lymphoma (PTCL)
n=23 Participants
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.
|
Cutaneous T-cell Lymphoma (CTCL)
n=19 Participants
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.
|
Small Lymphocytic Indolent B-Cell Lymphoma (IBCL)
n=15 Participants
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Drug-Related Adverse Events
|
2 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
T-Cell
Serious events: 9 serious events
Other events: 19 other events
Deaths: 0 deaths
Indolent B-Cell
Serious events: 11 serious events
Other events: 17 other events
Deaths: 0 deaths
Aggressive B-Cell
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
T-Cell
n=23 participants at risk
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.
|
Indolent B-Cell
n=19 participants at risk
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
n=15 participants at risk
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.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.7%
2/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Cardiac disorders
Cardiac failure
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Diarrhoea
|
8.7%
2/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
General disorders
Asthenia
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
General disorders
Mucosal inflammation
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
General disorders
Oedema
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
General disorders
Oedema peripheral
|
8.7%
2/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
General disorders
Pain
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
General disorders
Pyrexia
|
13.0%
3/23 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Hepatobiliary disorders
Jaundice
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Erysipelas
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Gastroenteritis
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Hepatitis b
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Lung infection
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Pneumonia
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
20.0%
3/15 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Sepsis
|
17.4%
4/23 • Number of events 5 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Septic shock
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Varicella
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
1/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-hodgkin's lymphoma
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Nervous system disorders
Coma
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Psychiatric disorders
Hallucinations, mixed
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
Other adverse events
| Measure |
T-Cell
n=23 participants at risk
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.
|
Indolent B-Cell
n=19 participants at risk
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
n=15 participants at risk
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.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Nodal osteoarthritis
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
21.7%
5/23 • Number of events 7 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Anaemia
|
21.7%
5/23 • Number of events 7 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
15.8%
3/19 • Number of events 11 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
20.0%
3/15 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
4.3%
1/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Retroperitoneal lymphadenopathy
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Splenomegaly
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.7%
2/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 4 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Ear and labyrinth disorders
Hypoacusis
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Ear and labyrinth disorders
Vestibular neuronitis
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Eye disorders
Eye discharge
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Eye disorders
Eye pruritus
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Eye disorders
Retinitis
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Abdominal pain
|
13.0%
3/23 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Ascites
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Constipation
|
13.0%
3/23 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Diarrhoea
|
17.4%
4/23 • Number of events 4 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
42.1%
8/19 • Number of events 14 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
20.0%
3/15 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Gastritis
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Gingival erythema
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Gingival oedema
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Nausea
|
8.7%
2/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
15.8%
3/19 • Number of events 4 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
13.3%
2/15 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
21.1%
4/19 • Number of events 4 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
13.3%
2/15 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
General disorders
Asthenia
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
General disorders
Chest pain
|
8.7%
2/23 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
General disorders
Chills
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
General disorders
Face oedema
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
General disorders
Fatigue
|
8.7%
2/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
36.8%
7/19 • Number of events 10 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
General disorders
Influenza like illness
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
General disorders
Malaise
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
General disorders
Oedema
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
15.8%
3/19 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
General disorders
Oedema peripheral
|
17.4%
4/23 • Number of events 4 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
15.8%
3/19 • Number of events 4 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
20.0%
3/15 • Number of events 6 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
General disorders
Pyrexia
|
26.1%
6/23 • Number of events 8 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
15.8%
3/19 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 4 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Hepatobiliary disorders
Hepatic failure
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Acarodermatitis
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Cellulitis
|
4.3%
1/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Central nervous system infection
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Fungal infection
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Gastrointestinal candidiasis
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Influenza
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Otitis media
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Pharyngitis
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Pneumonia
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
15.8%
3/19 • Number of events 4 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Sepsis
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Sinusitis
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Skin infection
|
8.7%
2/23 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Tinea infection
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Tinea pedis
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Tracheobronchitis
|
4.3%
1/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
13.3%
2/15 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Urinary tract infection
|
4.3%
1/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Alanine aminotransferase increased
|
8.7%
2/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Aspartate aminotransferase increased
|
8.7%
2/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Blood alkaline phosphatase increased
|
8.7%
2/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Blood creatinine increased
|
13.0%
3/23 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Blood glucose decreased
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Blood lactate dehydrogenase decreased
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Blood lactate dehydrogenase increased
|
8.7%
2/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Blood urea decreased
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Blood urea increased
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Cardiac murmur
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Eosinophil count increased
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Haemoglobin decreased
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
15.8%
3/19 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Neutrophil count increased
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Platelet count decreased
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
15.8%
3/19 • Number of events 4 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Prothrombin time prolonged
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
Weight decreased
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
15.8%
3/19 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Investigations
White blood cell count decreased
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
8.7%
2/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.7%
2/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.7%
2/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Malnutrition
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Tetany
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
2/23 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
1/23 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
1/23 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibromatosis
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ocular neoplasm
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal neoplasm
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Nervous system disorders
Dizziness
|
13.0%
3/23 • Number of events 4 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
13.3%
2/15 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Nervous system disorders
Headache
|
13.0%
3/23 • Number of events 6 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
21.1%
4/19 • Number of events 5 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Nervous system disorders
Somnolence
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Nervous system disorders
Syncope
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Psychiatric disorders
Depression
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Psychiatric disorders
Insomnia
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
15.8%
3/19 • Number of events 4 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Psychiatric disorders
Mental status changes
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
15.8%
3/19 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Renal and urinary disorders
Haematuria
|
8.7%
2/23 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Renal and urinary disorders
Pollakiuria
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
9.1%
1/11 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/14 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
9.1%
1/11 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
7.1%
1/14 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Reproductive system and breast disorders
Genital discharge
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/11 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
7.1%
1/14 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/12 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/5 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
14.3%
1/7 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
3/23 • Number of events 3 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
26.3%
5/19 • Number of events 7 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.7%
2/23 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Penile ulceration
|
9.1%
1/11 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/14 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/8 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.4%
4/23 • Number of events 5 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
15.8%
3/19 • Number of events 5 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
13.3%
2/15 • Number of events 4 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
15.8%
3/19 • Number of events 6 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
10.5%
2/19 • Number of events 2 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Vascular disorders
Hypertension
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
6.7%
1/15 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Vascular disorders
Hypotension
|
4.3%
1/23 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/19 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
|
Vascular disorders
Phlebitis
|
0.00%
0/23 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
5.3%
1/19 • Number of events 1 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
0.00%
0/15 • Up to 114 months
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60