Trial Outcomes & Findings for Investigation of Tipifarnib in Treatment of Subjects With Peripheral T-Cell Lymphoma (PTCL) That Have Not Responded to Standard Therapy (NCT NCT02464228)
NCT ID: NCT02464228
Last Updated: 2024-06-26
Results Overview
The ORR (complete response \[CR\] or partial response \[PRs\]) of tipifarnib was based on response assessments according to the Lugano Classification. Two-sided 95% confidence intervals (CIs) were based on either Wilson approximation (N \> 4) or Clopper-Pearson method (N ≤ 4). CR: PET-CT-based response, score of 1-3 on five-point scale (5PS) for lymph nodes and extralymphatic sites, no evidence of fluorodeoxyglucose (FDG)-avid disease in marrow. CT-based response, target nodes and masses regress to 1.5 cm in longest transverse diameter, no extralymphatic sites of disease, normal bone marrow morphology. PR: PET-CT-based response, score of 4-5 on 5PS with reduced uptake compared to baseline for lymph nodes and extralymphatic sites, residual uptake reduced compared to baseline in the bone marrow. CT-based response, ≥ 50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites, spleen regressed by \> 50% in length beyond normal.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Up to approximately 3 years
Results posted on
2024-06-26
Participant Flow
The first subject was enrolled on 25 Feb 2016 (13 in Europe; 52 outside Europe) and the date of the last visit was 31 Mar 2021. Overall, 65 subjects were enrolled into cohorts with angioimmunoblastic T-cell lymphoma (AITL), peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), PTCL-NOS whose tumors expressed high levels of C-X-C motif chemokine 12 (CXCL12+), and Other (anaplastic large cell lymphoma-anaplastic lymphoma kinase \[ALCL-ALK negative\] and PTCL-subtype not specified).
Only consented subjects who met all the eligibility criteria were enrolled in the study. All screening evaluations were to be completed within 4 weeks (28 days) of Cycle 1 Day 1. Screen failure reasons were not included in the database.
Participant milestones
| Measure |
Cohort AITL
Subjects with AITL received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally twice daily (BID) on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort PTCL-NOS
Subjects with PTCL-NOS (not including subjects with PTCL-NOS CXCL12+) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort PTCL-NOS, CXCL12+
Subjects with PTCL-NOS CXCL12+ (not including subjects with PTCL-NOS) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort Other
Subjects with other indications (including ALCL-ALK negative and PTCL-subtype not specified per protocol) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
38
|
14
|
11
|
2
|
|
Overall Study
COMPLETED
|
2
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
36
|
14
|
11
|
2
|
Reasons for withdrawal
| Measure |
Cohort AITL
Subjects with AITL received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally twice daily (BID) on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort PTCL-NOS
Subjects with PTCL-NOS (not including subjects with PTCL-NOS CXCL12+) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort PTCL-NOS, CXCL12+
Subjects with PTCL-NOS CXCL12+ (not including subjects with PTCL-NOS) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort Other
Subjects with other indications (including ALCL-ALK negative and PTCL-subtype not specified per protocol) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
|---|---|---|---|---|
|
Overall Study
Termination for Symptomatic Deterioration
|
1
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
1
|
0
|
|
Overall Study
Miscellaneous
|
1
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
9
|
0
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
0
|
|
Overall Study
Disease Progression
|
22
|
12
|
5
|
2
|
Baseline Characteristics
Investigation of Tipifarnib in Treatment of Subjects With Peripheral T-Cell Lymphoma (PTCL) That Have Not Responded to Standard Therapy
Baseline characteristics by cohort
| Measure |
Cohort AITL
n=38 Participants
Subjects with AITL received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort PTCL-NOS
n=14 Participants
Subjects with PTCL-NOS (not including subjects with PTCL-NOS CXCL12+) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort PTCL-NOS, CXCL12+
n=11 Participants
Subjects with PTCL-NOS CXCL12+ (not including subjects with PTCL-NOS) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort Other
n=2 Participants
Subjects with other indications (including ALCL-ALK negative and PTCL-subtype not specified per protocol) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.50 years
STANDARD_DEVIATION 10.7 • n=93 Participants
|
65.73 years
STANDARD_DEVIATION 13.7 • n=4 Participants
|
65.74 years
STANDARD_DEVIATION 12.6 • n=27 Participants
|
56.68 years
STANDARD_DEVIATION 12.0 • n=483 Participants
|
65.32 years
STANDARD_DEVIATION 11.6 • n=36 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
41 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
61 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
46 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Score
Performance Score 0
|
18 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
26 Participants
n=36 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Score
Performance Score 1
|
13 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
31 Participants
n=36 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Score
Performance Score 2
|
7 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 3 yearsPopulation: The Full Analysis Set (FAS) Population excluding subjects for the following reasons: no baseline data; failure to receive at least 1 dose of tipifarnib; no post-baseline endpoint data subsequent to at least 1 dose of study drug.
The ORR (complete response \[CR\] or partial response \[PRs\]) of tipifarnib was based on response assessments according to the Lugano Classification. Two-sided 95% confidence intervals (CIs) were based on either Wilson approximation (N \> 4) or Clopper-Pearson method (N ≤ 4). CR: PET-CT-based response, score of 1-3 on five-point scale (5PS) for lymph nodes and extralymphatic sites, no evidence of fluorodeoxyglucose (FDG)-avid disease in marrow. CT-based response, target nodes and masses regress to 1.5 cm in longest transverse diameter, no extralymphatic sites of disease, normal bone marrow morphology. PR: PET-CT-based response, score of 4-5 on 5PS with reduced uptake compared to baseline for lymph nodes and extralymphatic sites, residual uptake reduced compared to baseline in the bone marrow. CT-based response, ≥ 50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites, spleen regressed by \> 50% in length beyond normal.
Outcome measures
| Measure |
Cohort AITL
n=32 Participants
Subjects with AITL received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort PTCL-NOS
n=14 Participants
Subjects with PTCL-NOS (not including subjects with PTCL-NOS CXCL12+) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort PTCL-NOS, CXCL12+
n=10 Participants
Subjects with PTCL-NOS CXCL12+ (not including subjects with PTCL-NOS) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort Other
n=2 Participants
Subjects with other indications (including ALCL-ALK negative and PTCL-subtype not specified per protocol) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
56.3 percentage of participants
Interval 39.3 to 71.8
|
7.1 percentage of participants
Interval 0.2 to 33.9
|
40.0 percentage of participants
Interval 12.2 to 73.8
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: The FAS Population excluding subjects for the following reasons: no Baseline data; failure to receive at least 1 dose of tipifarnib; no post-baseline endpoint data subsequent to at least 1 dose of study drug.
PFS was defined as the time (in months) from first dose (Cycle 1 Day 1) to either first observation of progressive disease (PD) or occurrence of death due to any cause within 126 days (approximately 2 time-intervals for tumor assessments) of either first administration of tipifarnib or the last tumor assessment. Observation of PD could have been by either documented radiographic progression (i.e., scan results) or documentation of symptomatic or clinical progression agreed upon and documented by investigators. In subjects without a progression date or with a death date more than 126 days after the first administration of study drugs or the last tumor assessment, the PFS time was censored on the date of last tumor assessment or date of first administration of study tipifarnib. The duration of the PFS was analyzed using the Kaplan-Meier (KM) method. 95% CIs were calculated using Hall-Wellner Method.
Outcome measures
| Measure |
Cohort AITL
n=32 Participants
Subjects with AITL received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort PTCL-NOS
n=14 Participants
Subjects with PTCL-NOS (not including subjects with PTCL-NOS CXCL12+) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort PTCL-NOS, CXCL12+
n=10 Participants
Subjects with PTCL-NOS CXCL12+ (not including subjects with PTCL-NOS) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort Other
n=2 Participants
Subjects with other indications (including ALCL-ALK negative and PTCL-subtype not specified per protocol) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
3.6 months
Interval 1.9 to 8.3
|
2.1 months
Interval 1.4 to 4.0
|
5.3 months
Interval 1.8 to 11.1
|
1.4 months
Interval 1.1 to 1.6
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: The FAS Population excluding subjects for the following reasons: no baseline data; failure to receive at least 1 dose of tipifarnib; no post-baseline endpoint data subsequent to at least 1 dose of study drug.
DOR was defined as the time (in months) from the start date of the objective response to the first date of either documented PD or death. No data imputations were conducted for missing data. In the event of a maintained response, the DOR was censored at the last evaluable non-PD assessment. The DOR was analyzed using the KM method. 95% CIs were calculated using Hall-Wellner Method.
Outcome measures
| Measure |
Cohort AITL
n=18 Participants
Subjects with AITL received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort PTCL-NOS
n=1 Participants
Subjects with PTCL-NOS (not including subjects with PTCL-NOS CXCL12+) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort PTCL-NOS, CXCL12+
n=4 Participants
Subjects with PTCL-NOS CXCL12+ (not including subjects with PTCL-NOS) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort Other
Subjects with other indications (including ALCL-ALK negative and PTCL-subtype not specified per protocol) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
|---|---|---|---|---|
|
Duration of Response (DOR)
|
7.8 months
Interval 2.0 to 16.3
|
1.0 months
Lower 95% CI could not be estimated as there were too few participants with events that impacted the estimate of DOR function and there was no variation as per the pre-specified analysis in the SAP.
|
2.8 months
Interval 2.0 to
Upper 95% CI was not reached as there were too few participants with events that impacted the estimate of DOR function.
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsPopulation: The ASaT population consists of all enrolled subjects who received at least 1 dose of tipifarnib.
An adverse event (AE) was any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs that started on or after the first dose of study drug and within 30 days of the last administration of study drug or immediately before the initiation of any other anticancer therapy. The Investigator was required to grade the severity/intensity of each AE according to NCI-CTCAE version 4.03. If a severity/intensity of Grade 4 (life-threatening) or 5 (death) was applied to an AE, then the Investigator also reported the event as a serious AE.
Outcome measures
| Measure |
Cohort AITL
n=38 Participants
Subjects with AITL received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort PTCL-NOS
n=14 Participants
Subjects with PTCL-NOS (not including subjects with PTCL-NOS CXCL12+) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort PTCL-NOS, CXCL12+
n=11 Participants
Subjects with PTCL-NOS CXCL12+ (not including subjects with PTCL-NOS) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort Other
n=2 Participants
Subjects with other indications (including ALCL-ALK negative and PTCL-subtype not specified per protocol) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
|---|---|---|---|---|
|
Number of Subjects That Experienced One or More Treatment-emergent Adverse Events (TEAEs)
TEAEs
|
38 Participants
|
14 Participants
|
11 Participants
|
2 Participants
|
|
Number of Subjects That Experienced One or More Treatment-emergent Adverse Events (TEAEs)
Serious TEAEs
|
21 Participants
|
8 Participants
|
8 Participants
|
1 Participants
|
Adverse Events
Cohort AITL
Serious events: 21 serious events
Other events: 38 other events
Deaths: 13 deaths
Cohort PTCL-NOS
Serious events: 8 serious events
Other events: 14 other events
Deaths: 8 deaths
Cohort PTCL-NOS, CXCL12+
Serious events: 8 serious events
Other events: 11 other events
Deaths: 4 deaths
Cohort Other
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort AITL
n=38 participants at risk
Subjects with AITL received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort PTCL-NOS
n=14 participants at risk
Subjects with PTCL-NOS (not including subjects with PTCL-NOS CXCL12+) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort PTCL-NOS, CXCL12+
n=11 participants at risk
Subjects with PTCL-NOS CXCL12+ (not including subjects with PTCL-NOS) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort Other
n=2 participants at risk
Subjects with other indications (including ALCL-ALK negative and PTCL-subtype not specified per protocol) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
General disorders
Death
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
General disorders
Pyrexia
|
5.3%
2/38 • Up to approximately 3 years
|
21.4%
3/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
General disorders
Malaise
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Psychiatric disorders
Delirium
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
1/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Cardiac disorders
Atrioventricular block second degree
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Cardiac disorders
Cardiac failure
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Cardiac disorders
Cardiopulmonary failure
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.9%
3/38 • Up to approximately 3 years
|
28.6%
4/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Pancytopenia
|
7.9%
3/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Cytopenia
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Nervous system disorders
Encephalopathy
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Nervous system disorders
Syncope
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.3%
2/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Cellulitis
|
2.6%
1/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Kidney infection
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Lung infection
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Pneumonia
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Sepsis
|
2.6%
1/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
Other adverse events
| Measure |
Cohort AITL
n=38 participants at risk
Subjects with AITL received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort PTCL-NOS
n=14 participants at risk
Subjects with PTCL-NOS (not including subjects with PTCL-NOS CXCL12+) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort PTCL-NOS, CXCL12+
n=11 participants at risk
Subjects with PTCL-NOS CXCL12+ (not including subjects with PTCL-NOS) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
Cohort Other
n=2 participants at risk
Subjects with other indications (including ALCL-ALK negative and PTCL-subtype not specified per protocol) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles.
In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
|
|---|---|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Vascular disorders
Haematoma
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Vascular disorders
Hypotension
|
21.1%
8/38 • Up to approximately 3 years
|
14.3%
2/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
General disorders
Asthenia
|
7.9%
3/38 • Up to approximately 3 years
|
21.4%
3/14 • Up to approximately 3 years
|
27.3%
3/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
General disorders
Chest pain
|
2.6%
1/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
General disorders
Chills
|
10.5%
4/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
18.2%
2/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
General disorders
Fatigue
|
50.0%
19/38 • Up to approximately 3 years
|
50.0%
7/14 • Up to approximately 3 years
|
18.2%
2/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
General disorders
Gait disturbance
|
5.3%
2/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
General disorders
Decreased activity
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
General disorders
Influenza like illness
|
2.6%
1/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
General disorders
Malaise
|
2.6%
1/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
18.2%
2/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
General disorders
Oedema peripheral
|
7.9%
3/38 • Up to approximately 3 years
|
21.4%
3/14 • Up to approximately 3 years
|
36.4%
4/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
General disorders
Pain
|
5.3%
2/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
General disorders
Medical device pain
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
General disorders
Pyrexia
|
34.2%
13/38 • Up to approximately 3 years
|
14.3%
2/14 • Up to approximately 3 years
|
27.3%
3/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/38 • Up to approximately 3 years
|
14.3%
2/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Psychiatric disorders
Agitation
|
0.00%
0/38 • Up to approximately 3 years
|
14.3%
2/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Psychiatric disorders
Anxiety
|
7.9%
3/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Psychiatric disorders
Confusional state
|
2.6%
1/38 • Up to approximately 3 years
|
14.3%
2/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Psychiatric disorders
Insomnia
|
13.2%
5/38 • Up to approximately 3 years
|
21.4%
3/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
2/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
18.2%
2/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
7.9%
3/38 • Up to approximately 3 years
|
14.3%
2/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Periorbital haemorrhage
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
Alanine aminotransferase increased
|
2.6%
1/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
2/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
Blood alkaline phosphatase increased
|
2.6%
1/38 • Up to approximately 3 years
|
14.3%
2/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/38 • Up to approximately 3 years
|
21.4%
3/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
Blood creatinine increased
|
13.2%
5/38 • Up to approximately 3 years
|
35.7%
5/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
Blood urea increased
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
Blood uric acid increased
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
Epstein-Barr virus test positive
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.3%
2/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
Human rhinovirus test positive
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
International normalised ratio increased
|
2.6%
1/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
Lymphocyte count decreased
|
10.5%
4/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
Monocyte count decreased
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
Neutrophil count decreased
|
28.9%
11/38 • Up to approximately 3 years
|
57.1%
8/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
Platelet count decreased
|
39.5%
15/38 • Up to approximately 3 years
|
71.4%
10/14 • Up to approximately 3 years
|
36.4%
4/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Investigations
Urine output increased
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
Weight decreased
|
10.5%
4/38 • Up to approximately 3 years
|
42.9%
6/14 • Up to approximately 3 years
|
18.2%
2/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Investigations
White blood cell count decreased
|
10.5%
4/38 • Up to approximately 3 years
|
21.4%
3/14 • Up to approximately 3 years
|
18.2%
2/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
7.9%
3/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Cardiac disorders
Tachycardia
|
5.3%
2/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.1%
8/38 • Up to approximately 3 years
|
21.4%
3/14 • Up to approximately 3 years
|
18.2%
2/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.3%
2/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.5%
4/38 • Up to approximately 3 years
|
42.9%
6/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.9%
3/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.9%
3/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.3%
2/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.3%
2/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.3%
2/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Anaemia
|
42.1%
16/38 • Up to approximately 3 years
|
71.4%
10/14 • Up to approximately 3 years
|
54.5%
6/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.3%
2/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.6%
1/38 • Up to approximately 3 years
|
28.6%
4/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.6%
1/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.8%
6/38 • Up to approximately 3 years
|
28.6%
4/14 • Up to approximately 3 years
|
27.3%
3/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.9%
3/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Nervous system disorders
Dizziness
|
21.1%
8/38 • Up to approximately 3 years
|
14.3%
2/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Nervous system disorders
Dysgeusia
|
5.3%
2/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Nervous system disorders
Headache
|
13.2%
5/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
100.0%
2/2 • Up to approximately 3 years
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.5%
4/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Nervous system disorders
Sciatica
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Nervous system disorders
Sinus headache
|
2.6%
1/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Nervous system disorders
Somnolence
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/38 • Up to approximately 3 years
|
14.3%
2/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Eye disorders
Vision blurred
|
5.3%
2/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Eye disorders
Macular degeneration
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
13.2%
5/38 • Up to approximately 3 years
|
14.3%
2/14 • Up to approximately 3 years
|
18.2%
2/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/38 • Up to approximately 3 years
|
14.3%
2/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Constipation
|
13.2%
5/38 • Up to approximately 3 years
|
35.7%
5/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Diarrhoea
|
36.8%
14/38 • Up to approximately 3 years
|
57.1%
8/14 • Up to approximately 3 years
|
18.2%
2/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
2/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
18.2%
2/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
13.2%
5/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
18.2%
2/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Gastritis
|
5.3%
2/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Gastrointestinal wall thickening
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Nausea
|
31.6%
12/38 • Up to approximately 3 years
|
64.3%
9/14 • Up to approximately 3 years
|
36.4%
4/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Stomatitis
|
7.9%
3/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Toothache
|
2.6%
1/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
6/38 • Up to approximately 3 years
|
35.7%
5/14 • Up to approximately 3 years
|
27.3%
3/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
5.3%
2/38 • Up to approximately 3 years
|
21.4%
3/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Renal and urinary disorders
Urinary retention
|
2.6%
1/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.3%
2/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
5.3%
2/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.3%
10/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
18.2%
2/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.7%
9/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.2%
5/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
18.2%
2/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
13.2%
5/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.9%
3/38 • Up to approximately 3 years
|
28.6%
4/14 • Up to approximately 3 years
|
18.2%
2/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
1/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
18.2%
2/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.3%
2/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.3%
2/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.6%
1/38 • Up to approximately 3 years
|
14.3%
2/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
18.4%
7/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
27.3%
3/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
1/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
34.2%
13/38 • Up to approximately 3 years
|
50.0%
7/14 • Up to approximately 3 years
|
18.2%
2/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
13.2%
5/38 • Up to approximately 3 years
|
28.6%
4/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.9%
3/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.6%
1/38 • Up to approximately 3 years
|
14.3%
2/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.3%
2/38 • Up to approximately 3 years
|
14.3%
2/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.3%
2/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.3%
2/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
23.7%
9/38 • Up to approximately 3 years
|
35.7%
5/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.2%
5/38 • Up to approximately 3 years
|
35.7%
5/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.3%
2/38 • Up to approximately 3 years
|
50.0%
7/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.6%
1/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Vitamin B1 deficiency
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Clostridium difficile infection
|
2.6%
1/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Herpes zoster
|
5.3%
2/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
|
Infections and infestations
Oral candidiasis
|
10.5%
4/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
18.2%
2/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
18.2%
2/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Pneumonia
|
10.5%
4/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Rash pustular
|
0.00%
0/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Sepsis
|
2.6%
1/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Sinusitis
|
5.3%
2/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Streptoccocal urinary tract infection
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Upper respiratory tract infection
|
13.2%
5/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Urinary tract infection
|
7.9%
3/38 • Up to approximately 3 years
|
7.1%
1/14 • Up to approximately 3 years
|
9.1%
1/11 • Up to approximately 3 years
|
0.00%
0/2 • Up to approximately 3 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/38 • Up to approximately 3 years
|
0.00%
0/14 • Up to approximately 3 years
|
0.00%
0/11 • Up to approximately 3 years
|
50.0%
1/2 • Up to approximately 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There are agreements in place between clinical trial sites and the Sponsor (or its agents) that govern discussion or publication of trial results by the sites or their employees after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER