Trial Outcomes & Findings for Delanzomib (CEP-18770) in Combination With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (NCT NCT01348919)
NCT ID: NCT01348919
Last Updated: 2023-06-28
Results Overview
The ORR is defined as percentage of participants who achieve a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) during the study. sCR: negative immunofixation in serum and urine; disappearance of any soft tissue plasmacytomas; \< 5% plasma cells in bone marrow; normal free light chain (FLC) ratio; and absence of clonal cells in bone marrow. CR: negative immunofixation in serum and urine; disappearance of any soft tissue plasmacytomas; and \<5% plasma cells in bone marrow. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis; 90% or greater reduction in serum M-protein level and urine M-protein level less than 100 milligrams (mg)/24 hours. PR: ≥50% reduction in serum M-protein level; ≥90% reduction in 24-hour urinary M-protein level or reduction to less than 200 mg per 24 hours; and ≥50% reduction in the size of any soft tissue plasmacytomas present at baseline.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
From the first administration of CEP-18770 up to approximately 1.5 years
Results posted on
2023-06-28
Participant Flow
Participant milestones
| Measure |
CEP-18770 Dose A
Participants received Dose A intravenously (IV) on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose B
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose C
Participants received CEP-18770 Dose C IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
3
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
3
|
5
|
3
|
|
Overall Study
COMPLETED
|
0
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
1
|
Reasons for withdrawal
| Measure |
CEP-18770 Dose A
Participants received Dose A intravenously (IV) on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose B
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose C
Participants received CEP-18770 Dose C IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Disease progression
|
0
|
1
|
1
|
Baseline Characteristics
Delanzomib (CEP-18770) in Combination With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
CEP-18770 Dose A
n=3 Participants
Participants received Dose A intravenously (IV) on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose B
n=5 Participants
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose C
n=3 Participants
Participants received CEP-18770 Dose C IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 3.06 • n=93 Participants
|
61.4 years
STANDARD_DEVIATION 11.67 • n=4 Participants
|
57.7 years
STANDARD_DEVIATION 15.37 • n=27 Participants
|
61.2 years
STANDARD_DEVIATION 10.51 • n=483 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
11 Participants
n=483 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
|
|
Race/Ethnicity, Customized
Race · White
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: From the first administration of CEP-18770 up to approximately 1.5 yearsPopulation: The full analysis set included all participants who received at least 1 dose of CEP-18770 at the MTD, including participants treated at the MTD of CEP-18770 in Part 1 and who had at least 1 response assessment, or who discontinued treatment due to toxicity or death. Participants who did not have a response assessment were considered non-responders.
The ORR is defined as percentage of participants who achieve a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) during the study. sCR: negative immunofixation in serum and urine; disappearance of any soft tissue plasmacytomas; \< 5% plasma cells in bone marrow; normal free light chain (FLC) ratio; and absence of clonal cells in bone marrow. CR: negative immunofixation in serum and urine; disappearance of any soft tissue plasmacytomas; and \<5% plasma cells in bone marrow. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis; 90% or greater reduction in serum M-protein level and urine M-protein level less than 100 milligrams (mg)/24 hours. PR: ≥50% reduction in serum M-protein level; ≥90% reduction in 24-hour urinary M-protein level or reduction to less than 200 mg per 24 hours; and ≥50% reduction in the size of any soft tissue plasmacytomas present at baseline.
Outcome measures
| Measure |
CEP-18770 Dose B
n=5 Participants
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose B
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose C
Participants received CEP-18770 Dose C IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
|---|---|---|---|
|
Overall Response Rate (ORR) in Participants Treated at the (Maximum Tolerated Dose) MTD, as Assessed Using International Myeloma Working Group (IMWG) Criteria
|
40 percentage of participants
Interval 5.27 to 85.34
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 (28 days)Population: The MTD determination set included all participants who received at least 3 doses of the study drug during the first cycle. In addition, any participant who experienced a drug related DLT during Cycle 1 was considered evaluable regardless of the number of doses received.
MTD was based on the assessment of dose-limiting toxicity (DLT) during cycle 1 only and was defined as the highest dose at which fewer than one-third of participants in a cohort experience DLT. A DLT was defined as any of the following drug-related toxicities occurring during Cycle 1: Hematologic adverse events (AEs) (Grade 4 hematologic AEs, Grade 3 hematologic AEs with sequelae); Grade 3 nonhematologic AEs; Neuropathy (Grade 2 neuropathy, Grade 1 neuropathy with pain, worsening grade of neuropathy or new symptoms of pain associated with neuropathy); Any other toxicity that, in the judgment of the principal investigator, was a DLT; If a participant cannot receive 75% of the planned dose for any of the 3 agents (missing \>1 dose of CEP-18770, or \>5 doses of lenalidomide, or \>1 dose of dexamethasone \[either consecutively or separately\]), due to a drug-related AE, the event was considered a DLT, even if the grade of toxicity was lower than specified DLT determination as described above.
Outcome measures
| Measure |
CEP-18770 Dose B
n=11 Participants
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose B
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose C
Participants received CEP-18770 Dose C IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
|---|---|---|---|
|
Maximum Tolerated Dose of CEP-18770
|
1.8 mg/m^2
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of first response to the date of disease progression (up to approximately 1.5 years)Population: The full analysis set included all participants who received at least 1 dose of CEP-18770 at the MTD, including participants treated at the MTD of CEP-18770 in Part 1 and who had at least 1 response assessment, or who discontinued treatment due to toxicity or death. Participants who did not have a response assessment were considered non-responders. Overall number of participants analyzed = participants with a response of sCR, CR, VGPR, or PR.
DOR was defined as the time interval from the date of first response (sCR, CR, VGPR, or PR) to the date of disease progression. sCR, CR, VGPR, and PR as defined in outcome measure 1. Disease progression was defined as any 1 or more of the following: Increase of 25% or more from lowest response level in any 1 or more of the following: - serum M-component (absolute increase must be ≥0.5 grams \[g\]/deciliter \[dL\]), - urine M-component (absolute increase must be ≥200 mg/24 hours), bone marrow plasma cell percentage ≥10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; and development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that could be attributed solely to the plasma cell proliferation disorder.
Outcome measures
| Measure |
CEP-18770 Dose B
n=2 Participants
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose B
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose C
Participants received CEP-18770 Dose C IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
|---|---|---|---|
|
Duration of Response (DOR) for Participants Treated With CEP-18770 at the MTD, as Assessed Using IMWG Criteria
|
NA months
No participants with a response had an event of disease progression or death, hence the data could not be calculated.
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of first dose of study drug to the date of disease progression (up to approximately 1.5 years)Population: The full analysis set included all participants who received at least 1 dose of CEP-18770 at the MTD, including participants treated at the MTD of CEP-18770 in Part 1 and who had at least 1 response assessment, or who discontinued treatment due to toxicity or death. Participants who did not have a response assessment were considered non-responders.
TTP was defined as the time interval from the date of first dose to the date of disease progression. Disease progression was defined as any 1 or more of the following: Increase of 25% or more from lowest response level in any 1 or more of the following: - serum M-component (absolute increase must be ≥0.5 g/dL), - urine M-component (absolute increase must be ≥200 mg/24 hours), bone marrow plasma cell percentage ≥10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; and development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that could be attributed solely to the plasma cell proliferation disorder.
Outcome measures
| Measure |
CEP-18770 Dose B
n=5 Participants
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose B
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose C
Participants received CEP-18770 Dose C IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
|---|---|---|---|
|
Time to Progression (TTP) for Participants Treated With CEP-18770 at the MTD, as Assessed Using IMWG Criteria
|
NA months
Interval 10.2 to
Due to small number of participants with an event, median and upper limit of 95% confidence interval (CI) could not be calculated.
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first administration of CEP-18770 up to approximately 1.5 yearsPopulation: Safety analysis set included all participants who received at least 1 dose of CEP-18770.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
CEP-18770 Dose B
n=3 Participants
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose B
n=5 Participants
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose C
n=3 Participants
Participants received CEP-18770 Dose C IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
3 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Before and immediately after end of infusion (EOI) and at approximately 2, 4, and 8 hours after the EOI on Days 1 and 15 of Cycle 1Population: The pharmacokinetic (PK) analysis set included all participants for whom at least 1 PK parameter can be calculated. Here, number analyzed = participants evaluable at specified timepoint.
Outcome measures
| Measure |
CEP-18770 Dose B
n=3 Participants
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose B
n=5 Participants
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose C
n=3 Participants
Participants received CEP-18770 Dose C IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of CEP-18770
Day 1
|
579.49 nanograms (ng)/ milliliter (mL)
Standard Deviation 118.48
|
663.00 nanograms (ng)/ milliliter (mL)
Standard Deviation 164.84
|
876.97 nanograms (ng)/ milliliter (mL)
Standard Deviation 211.99
|
|
Maximum Observed Plasma Concentration (Cmax) of CEP-18770
Day 15
|
639.59 nanograms (ng)/ milliliter (mL)
Standard Deviation 242.96
|
628.07 nanograms (ng)/ milliliter (mL)
Standard Deviation 291.34
|
977.09 nanograms (ng)/ milliliter (mL)
|
SECONDARY outcome
Timeframe: Before and immediately after end of infusion (EOI) and at approximately 2, 4, and 8 hours after the EOI on Days 1 and 15 of Cycle 1Population: The PK analysis set included all participants for whom at least 1 PK parameter can be calculated. Here, number analyzed = participants evaluable at specified timepoint.
Outcome measures
| Measure |
CEP-18770 Dose B
n=3 Participants
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose B
n=5 Participants
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose C
n=3 Participants
Participants received CEP-18770 Dose C IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
|---|---|---|---|
|
Time to Reach Cmax (Tmax) of CEP-18770
Day 15
|
0.07 hours
Interval 0.05 to 0.08
|
0.08 hours
Interval 0.05 to 0.15
|
0.08 hours
Interval 0.08 to 0.08
|
|
Time to Reach Cmax (Tmax) of CEP-18770
Day 1
|
0.07 hours
Interval 0.03 to 0.12
|
0.08 hours
Interval 0.05 to 0.18
|
0.10 hours
Interval 0.08 to 0.13
|
SECONDARY outcome
Timeframe: Before and immediately after end of infusion (EOI) and at approximately 2, 4, and 8 hours after the EOI on Days 1 and 15 of Cycle 1Population: PK analysis set included all participants for whom at least 1 PK parameter can be calculated. Here, number analyzed = participants evaluable at specified timepoint.
Outcome measures
| Measure |
CEP-18770 Dose B
n=3 Participants
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose B
n=5 Participants
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose C
n=3 Participants
Participants received CEP-18770 Dose C IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to t (AUC0-t) of CEP-18770
Day 1
|
673 ng*hours/mL
Standard Deviation 618
|
1371 ng*hours/mL
Standard Deviation 656
|
1527 ng*hours/mL
Standard Deviation 357
|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to t (AUC0-t) of CEP-18770
Day 15
|
1595 ng*hours/mL
Standard Deviation 677
|
2071 ng*hours/mL
Standard Deviation 1240
|
2266 ng*hours/mL
|
Adverse Events
CEP-18770 Dose A
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
CEP-18770 Dose B
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
CEP-18770 Dose C
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CEP-18770 Dose A
n=3 participants at risk
Participants received Dose A intravenously (IV) on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose B
n=5 participants at risk
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose C
n=3 participants at risk
Participants received CEP-18770 Dose C IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
Other adverse events
| Measure |
CEP-18770 Dose A
n=3 participants at risk
Participants received Dose A intravenously (IV) on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose B
n=5 participants at risk
Participants received CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
CEP-18770 Dose C
n=3 participants at risk
Participants received CEP-18770 Dose C IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants received a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
60.0%
3/5 • Number of events 16 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
66.7%
2/3 • Number of events 5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
66.7%
2/3 • Number of events 8 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Eye disorders
Blepharitis
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Eye disorders
Glaucoma
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
60.0%
3/5 • Number of events 4 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
100.0%
3/3 • Number of events 5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
80.0%
4/5 • Number of events 4 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Gastrointestinal disorders
Oral pain
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
General disorders
Chest pain
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
80.0%
4/5 • Number of events 4 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
100.0%
3/3 • Number of events 3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
General disorders
Inflammation
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
General disorders
Infusion site phlebitis
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
General disorders
Malaise
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
40.0%
2/5 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
General disorders
Pain
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
66.7%
2/3 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Infections and infestations
Oral candidiasis
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
60.0%
3/5 • Number of events 4 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
66.7%
2/3 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
66.7%
2/3 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Investigations
Neutrophil percentage decreased
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Investigations
Urine output decreased
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
66.7%
2/3 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
66.7%
2/3 • Number of events 4 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
66.7%
2/3 • Number of events 4 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
40.0%
2/5 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
66.7%
2/3 • Number of events 6 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
40.0%
2/5 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
66.7%
2/3 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
66.7%
2/3 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
40.0%
2/5 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/5 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
60.0%
3/5 • Number of events 3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
40.0%
2/5 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
40.0%
2/5 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Vascular disorders
Hot flush
|
33.3%
1/3 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 1 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
20.0%
1/5 • Number of events 2 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
0.00%
0/3 • From the first administration of CEP-18770 up to approximately 1.5 years
Safety analysis set included all participants who received at least 1 dose of CEP-18770.
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products R&D, Inc.
Phone: 1-888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER