Trial Outcomes & Findings for A Study LY2228820 for Recurrent Ovarian Cancer (NCT NCT01663857)
NCT ID: NCT01663857
Last Updated: 2019-09-11
Results Overview
Recommended Phase 2 dose of LY2228820 that could be safely administered in combination with gemcitabine and carboplatin based on defined dose limiting toxicities (DLT) assessment and MTD definition. The MTD is defined as the highest dose level at which no more than 33% of patients experience a DLT during Cycle 1 that does not exceed the single-agent MTD for LY2228820 (300 mg Q12H).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
118 participants
Primary outcome timeframe
Cycle 1 (21 Days)
Results posted on
2019-09-11
Participant Flow
Participants in Phase 1b are considered to have completed the study if they experience a dose-limiting toxicity or completed the Pharmacokinetic (PK) sampling set. Participants in Phase 2 are considered to have completed if they die due to any cause or who are alive and on study at conclusion, but are off treatment.
Participant milestones
| Measure |
Phase 1b: Cohort 1: LY2228820 + Gemcitabine + Carboplatin
Cohort 1:LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6).
Gemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10 of a 21-day cycle.
Carboplatin area under the concentration curve (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.
Cohort 1: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+).
|
Phase 1b: Cohort 2: LY2228820 + Gemcitabine + Carboplatin
Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10 of a 21-day cycle.
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.
Cohort 2: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+).
|
Phase 2: Arm A: LY2228820 + Gemcitabine + Carboplatin
Arm A: LY2228820 200 mg orally every 12 hr. on Days 1-10 of a 21-day cycle.
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.
Arm A: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)
|
Phase 2: Arm B: Placebo + Gemcitabine + Carboplatin
Arm B: Placebo orally every 12 hrs. on Days 1-10 of a 21-day cycle.
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.
Arm B: Placebo orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
58
|
52
|
|
Overall Study
Received at Least One Dose of Study Drug
|
6
|
2
|
58
|
52
|
|
Overall Study
COMPLETED
|
6
|
1
|
48
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
10
|
4
|
Reasons for withdrawal
| Measure |
Phase 1b: Cohort 1: LY2228820 + Gemcitabine + Carboplatin
Cohort 1:LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6).
Gemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10 of a 21-day cycle.
Carboplatin area under the concentration curve (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.
Cohort 1: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+).
|
Phase 1b: Cohort 2: LY2228820 + Gemcitabine + Carboplatin
Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10 of a 21-day cycle.
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.
Cohort 2: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+).
|
Phase 2: Arm A: LY2228820 + Gemcitabine + Carboplatin
Arm A: LY2228820 200 mg orally every 12 hr. on Days 1-10 of a 21-day cycle.
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.
Arm A: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)
|
Phase 2: Arm B: Placebo + Gemcitabine + Carboplatin
Arm B: Placebo orally every 12 hrs. on Days 1-10 of a 21-day cycle.
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.
Arm B: Placebo orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)
|
|---|---|---|---|---|
|
Overall Study
Withdrew Consent to Study Participation
|
0
|
1
|
7
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
1
|
Baseline Characteristics
Maintenance therapy as part of or after first line platinum regimen data was used as a cofactor in the analysis of Progression Free Survival (PFS). Zero participants analyzed for Phase 1 portion of the study.Data was collected only from participants treated in the Phase 2 portion of the study.
Baseline characteristics by cohort
| Measure |
Phase 1b: Cohort 1: LY2228820 +Gemcitabine+Carboplatin
n=6 Participants
Cohort 1:LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6).
Gemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10.
Carboplatin area under the concentration curve administered intravenously (IV) over 30 minutes (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3.
Cohort 1: LY2228820 300 mg orally every 12 hr. on Days 1-10 of a 21-day cycle (Cycles 1-6).
|
Phase 1b: Cohort 2: LY2228820 +Gemcitabine+Carboplatin
n=2 Participants
Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10 of a 21-day cycle (Cycles 1-6).
Gemcitabine 1000 mg/m2 administered IV over 30 min on Days 3 and 10.
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3.
Cohort 2:LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+).
|
Arm A: LY2228820 + Gemcitabine + Carboplatin
n=58 Participants
Arm A:LY2228820 200 mg orally every 12 hr. on Days 1-10 of a 21-day cycle (Cycles 1-6).
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10.
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3.
Arm A:LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+).
|
Arm B Placebo + Gemcitabine +Carboplatin
n=52 Participants
Arm B: Placebo orally every 12 hrs. on Days 1-10 of a 21-day cycle (Cycles 1-6).
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10.
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3.
Arm B: Placebo orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+).
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 6.8 • n=6 Participants
|
65.0 years
STANDARD_DEVIATION 5.7 • n=2 Participants
|
60.9 years
STANDARD_DEVIATION 10.4 • n=58 Participants
|
62.2 years
STANDARD_DEVIATION 9.2 • n=52 Participants
|
61.6 years
STANDARD_DEVIATION 9.6 • n=118 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=6 Participants
|
2 Participants
n=2 Participants
|
58 Participants
n=58 Participants
|
52 Participants
n=52 Participants
|
118 Participants
n=118 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=118 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=118 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=58 Participants
|
2 Participants
n=52 Participants
|
2 Participants
n=118 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=118 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=58 Participants
|
0 Participants
n=52 Participants
|
2 Participants
n=118 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
57 Participants
n=58 Participants
|
49 Participants
n=52 Participants
|
113 Participants
n=118 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=118 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=58 Participants
|
1 Participants
n=52 Participants
|
1 Participants
n=118 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
11 Participants
n=58 Participants
|
9 Participants
n=52 Participants
|
20 Participants
n=118 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=6 Participants
|
2 Participants
n=2 Participants
|
30 Participants
n=58 Participants
|
25 Participants
n=52 Participants
|
62 Participants
n=118 Participants
|
|
Region of Enrollment
Australia
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
4 Participants
n=58 Participants
|
6 Participants
n=52 Participants
|
10 Participants
n=118 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
13 Participants
n=58 Participants
|
12 Participants
n=52 Participants
|
26 Participants
n=118 Participants
|
|
Maintenance Therapy as a Part of or After a First Line Platinum Regimen
Received Maintenance Therapy
|
—
|
—
|
7 Participants
n=58 Participants • Maintenance therapy as part of or after first line platinum regimen data was used as a cofactor in the analysis of Progression Free Survival (PFS). Zero participants analyzed for Phase 1 portion of the study.Data was collected only from participants treated in the Phase 2 portion of the study.
|
7 Participants
n=52 Participants • Maintenance therapy as part of or after first line platinum regimen data was used as a cofactor in the analysis of Progression Free Survival (PFS). Zero participants analyzed for Phase 1 portion of the study.Data was collected only from participants treated in the Phase 2 portion of the study.
|
14 Participants
n=110 Participants • Maintenance therapy as part of or after first line platinum regimen data was used as a cofactor in the analysis of Progression Free Survival (PFS). Zero participants analyzed for Phase 1 portion of the study.Data was collected only from participants treated in the Phase 2 portion of the study.
|
|
Maintenance Therapy as a Part of or After a First Line Platinum Regimen
Did Not Receive Maintenance Therapy
|
—
|
—
|
15 Participants
n=58 Participants • Maintenance therapy as part of or after first line platinum regimen data was used as a cofactor in the analysis of Progression Free Survival (PFS). Zero participants analyzed for Phase 1 portion of the study.Data was collected only from participants treated in the Phase 2 portion of the study.
|
15 Participants
n=52 Participants • Maintenance therapy as part of or after first line platinum regimen data was used as a cofactor in the analysis of Progression Free Survival (PFS). Zero participants analyzed for Phase 1 portion of the study.Data was collected only from participants treated in the Phase 2 portion of the study.
|
30 Participants
n=110 Participants • Maintenance therapy as part of or after first line platinum regimen data was used as a cofactor in the analysis of Progression Free Survival (PFS). Zero participants analyzed for Phase 1 portion of the study.Data was collected only from participants treated in the Phase 2 portion of the study.
|
|
Maintenance Therapy as a Part of or After a First Line Platinum Regimen
Data Missing or Not Collected
|
—
|
—
|
36 Participants
n=58 Participants • Maintenance therapy as part of or after first line platinum regimen data was used as a cofactor in the analysis of Progression Free Survival (PFS). Zero participants analyzed for Phase 1 portion of the study.Data was collected only from participants treated in the Phase 2 portion of the study.
|
30 Participants
n=52 Participants • Maintenance therapy as part of or after first line platinum regimen data was used as a cofactor in the analysis of Progression Free Survival (PFS). Zero participants analyzed for Phase 1 portion of the study.Data was collected only from participants treated in the Phase 2 portion of the study.
|
66 Participants
n=110 Participants • Maintenance therapy as part of or after first line platinum regimen data was used as a cofactor in the analysis of Progression Free Survival (PFS). Zero participants analyzed for Phase 1 portion of the study.Data was collected only from participants treated in the Phase 2 portion of the study.
|
PRIMARY outcome
Timeframe: Cycle 1 (21 Days)Population: All participants who received at least one dose of study drug in Phase 1b.
Recommended Phase 2 dose of LY2228820 that could be safely administered in combination with gemcitabine and carboplatin based on defined dose limiting toxicities (DLT) assessment and MTD definition. The MTD is defined as the highest dose level at which no more than 33% of patients experience a DLT during Cycle 1 that does not exceed the single-agent MTD for LY2228820 (300 mg Q12H).
Outcome measures
| Measure |
LY2228820 + Gemcitabine + Carboplatin
n=8 Participants
Cohort 1 : LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6)
Gemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10
Carboplatin area under the concentration curve (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3
Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3
Cohort 1 and 2: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)
|
Placebo + Gemcitabine + Carboplatin
Arm B: Placebo orally every 12 hrs. on Days 1-10 of 21-day cycles.
Gemcitabine 1000 mg/m2 IV over 30 min on Days 3 and 10 of 21-day cycles.
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. n Day 3 of 21-day cycles.
Arm B: Placebo orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+)
|
|---|---|---|
|
Phase 1b: Recommended Phase 2 Dose of LY2228820 in Combination With Gemcitabine and Carboplatin (Maximum Tolerated Dose [MTD])
|
200 milligrams (mg)
|
—
|
PRIMARY outcome
Timeframe: Randomization to Date of Disease Progression or Death from any cause (up to 3 years)Population: All participants in Phase 2 who received at least one dose of study drug.
PFS was defined as time from date of randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred first. Progressive disease (PD) is defined as at least a 20% increase in the sum of the largest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
LY2228820 + Gemcitabine + Carboplatin
n=58 Participants
Cohort 1 : LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6)
Gemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10
Carboplatin area under the concentration curve (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3
Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3
Cohort 1 and 2: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)
|
Placebo + Gemcitabine + Carboplatin
n=52 Participants
Arm B: Placebo orally every 12 hrs. on Days 1-10 of 21-day cycles.
Gemcitabine 1000 mg/m2 IV over 30 min on Days 3 and 10 of 21-day cycles.
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. n Day 3 of 21-day cycles.
Arm B: Placebo orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+)
|
|---|---|---|
|
Phase 2: Progression-free Survival (PFS) in Participants Treated With LY2228820 Plus Gemcitabine and Carboplatin Versus Placebo Plus Gemcitabine and Carboplatin
|
10.25 months
Interval 7.85 to 10.87
|
8.44 months
Interval 7.56 to 9.33
|
SECONDARY outcome
Timeframe: Baseline to Disease Progression (up to 3 years)Population: All participants who received at least one dose of study drug in Phase 2.
Overall Response Rate was estimated as the percentage of participants with best response of Complete Response (CR) or Partial Response (PR), based on RECIST version 1.1 divided by the total number of randomized participants. CR is defined as disappearance of all target lesions. PR is defined as at least 30% disease in the sum of the largest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
LY2228820 + Gemcitabine + Carboplatin
n=58 Participants
Cohort 1 : LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6)
Gemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10
Carboplatin area under the concentration curve (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3
Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3
Cohort 1 and 2: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)
|
Placebo + Gemcitabine + Carboplatin
n=52 Participants
Arm B: Placebo orally every 12 hrs. on Days 1-10 of 21-day cycles.
Gemcitabine 1000 mg/m2 IV over 30 min on Days 3 and 10 of 21-day cycles.
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. n Day 3 of 21-day cycles.
Arm B: Placebo orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+)
|
|---|---|---|
|
Phase 2: Percentage of Participants Who Achieve Complete Response or Partial Response (Overall Response Rate)
|
46.6 percentage of participants
|
46.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Date of Death from any cause (up to 5 years)Population: All participants in Phase 2 who received at least one dose of drug.
Data presented are the median overall survival in months for participants in the Phase 2 treatment arms.
Outcome measures
| Measure |
LY2228820 + Gemcitabine + Carboplatin
n=58 Participants
Cohort 1 : LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6)
Gemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10
Carboplatin area under the concentration curve (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3
Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3
Cohort 1 and 2: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)
|
Placebo + Gemcitabine + Carboplatin
n=52 Participants
Arm B: Placebo orally every 12 hrs. on Days 1-10 of 21-day cycles.
Gemcitabine 1000 mg/m2 IV over 30 min on Days 3 and 10 of 21-day cycles.
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. n Day 3 of 21-day cycles.
Arm B: Placebo orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+)
|
|---|---|---|
|
Phase 2: Overall Survival
|
29.17 months
Interval 23.26 to 52.4
|
25.10 months
Interval 21.95 to 33.68
|
SECONDARY outcome
Timeframe: Phase1b:Cycle(C)1 Day(D)1:Predose(PRD),0.5,1,2,4,6,8 hours(hr)postdose(PD); C1D10:PRD,0.5,1,2,8hrPD; C2D10:PRD,0.5,1,2,4,6,8,12hrPD; C7D3:PRD,0.5,1,2,4,6hrPD; Phase 2: C1D3:PRD,0.5,1,2,4,6,8hrPD; C1D10:PRD,0.5,1,2,4,6,8hrPD; C7D3:PRD,0.5,1,2,4,6,8hrPDPopulation: All participants in Phase 1b and Phase 2 who received at least one dose of study drug and had evaluable PK data.
PK parameters after administration of LY2228820 for both Phase 1b and Phase 2.
Outcome measures
| Measure |
LY2228820 + Gemcitabine + Carboplatin
n=13 Participants
Cohort 1 : LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6)
Gemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10
Carboplatin area under the concentration curve (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3
Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3
Cohort 1 and 2: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)
|
Placebo + Gemcitabine + Carboplatin
n=10 Participants
Arm B: Placebo orally every 12 hrs. on Days 1-10 of 21-day cycles.
Gemcitabine 1000 mg/m2 IV over 30 min on Days 3 and 10 of 21-day cycles.
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. n Day 3 of 21-day cycles.
Arm B: Placebo orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+)
|
|---|---|---|
|
Phase 1b and 2: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 8 Hours (AUC 0-8) of LY2228820
Cycle 7 Day 3
|
—
|
7230 nanograms * hr per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 72
|
|
Phase 1b and 2: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 8 Hours (AUC 0-8) of LY2228820
Cycle 1 Day 1
|
3470 nanograms * hr per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 91
|
3560 nanograms * hr per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 1
|
|
Phase 1b and 2: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 8 Hours (AUC 0-8) of LY2228820
Cycle 1 Day 3
|
3170 nanograms * hr per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 22
|
—
|
|
Phase 1b and 2: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 8 Hours (AUC 0-8) of LY2228820
Cycle 1 Day 10
|
4270 nanograms * hr per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 62
|
9350 nanograms * hr per milliliter (ng*hr/mL)
Geometric Coefficient of Variation NA
Due to n of 1 individual value provided.
|
|
Phase 1b and 2: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 8 Hours (AUC 0-8) of LY2228820
Cycle 2 Day 10
|
3270 nanograms * hr per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 38
|
3490 nanograms * hr per milliliter (ng*hr/mL)
Geometric Coefficient of Variation NA
Due to n of 1 individual value provided.
|
SECONDARY outcome
Timeframe: Baseline, Study Completion (up to 3 years)Population: All participants in Phase 2 who received at least one dose of study drug and had at least one post baseline assessment.
The Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) instrument measures health related quality of life (HRQoL) in participants with ovarian cancer. The instrument is organized into sections of physical, social/family, emotional, functional well-being and ovarian subscales with a 5-point rating scale in which 0 = "not at all" and 4 = "very much." Data presented here are change from baseline at follow-up in the FACT-O Total Score. The total score is the sum of Physical Well Being (PWB) + Social Well-being (SWB) + Emotional Well Being (EWB) + Family Well-being (FWB) + Ovarian Cancer Subscale (OCS). The FACT-O Total score range 0 - 152 with higher scores indicating better quality of life.
Outcome measures
| Measure |
LY2228820 + Gemcitabine + Carboplatin
n=58 Participants
Cohort 1 : LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6)
Gemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10
Carboplatin area under the concentration curve (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3
Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3
Cohort 1 and 2: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)
|
Placebo + Gemcitabine + Carboplatin
n=52 Participants
Arm B: Placebo orally every 12 hrs. on Days 1-10 of 21-day cycles.
Gemcitabine 1000 mg/m2 IV over 30 min on Days 3 and 10 of 21-day cycles.
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. n Day 3 of 21-day cycles.
Arm B: Placebo orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+)
|
|---|---|---|
|
Phase 2: Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) Total Score
|
-0.6 units on a scale
Standard Deviation 21.14
|
-8.9 units on a scale
Standard Deviation 19.92
|
Adverse Events
Phase 1b: Cohort 1: LY2228820 + Gemcitabine + Carboplatin
Serious events: 3 serious events
Other events: 6 other events
Deaths: 3 deaths
Phase 1b: Cohort 2: LY2228820 + Gemcitabine + Carboplatin
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Phase 2: Arm A: LY2228820 + Gemcitabine + Carboplatin
Serious events: 26 serious events
Other events: 58 other events
Deaths: 30 deaths
Phase 2: Arm B: Placebo + Gemcitabine + Carboplatin
Serious events: 12 serious events
Other events: 52 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
Phase 1b: Cohort 1: LY2228820 + Gemcitabine + Carboplatin
n=6 participants at risk
Cohort 1: LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6)
Gemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10
Carboplatin area under the concentration curve (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3
Cohort 1: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)
|
Phase 1b: Cohort 2: LY2228820 + Gemcitabine + Carboplatin
n=2 participants at risk
Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3
Cohort 2: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)
|
Phase 2: Arm A: LY2228820 + Gemcitabine + Carboplatin
n=58 participants at risk
Arm A: LY2228820 200 mg orally every 12 hr. on Days 1-10
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3
Arm A: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)
|
Phase 2: Arm B: Placebo + Gemcitabine + Carboplatin
n=52 participants at risk
Arm B: Placebo orally every 12 hrs. on Days 1-10
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3
Arm B: Placebo orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.2%
3/58 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
8.6%
5/58 • Number of events 7 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.2%
3/58 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.2%
3/58 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.8%
2/52 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
16.7%
1/6 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.8%
2/52 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
General disorders
General physical health deterioration
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
General disorders
Malaise
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Abscess
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Ureteritis
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Injury, poisoning and procedural complications
Urostomy complication
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Investigations
Nuclear magnetic resonance imaging abdominal abnormal
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
1/2 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
Other adverse events
| Measure |
Phase 1b: Cohort 1: LY2228820 + Gemcitabine + Carboplatin
n=6 participants at risk
Cohort 1: LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6)
Gemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10
Carboplatin area under the concentration curve (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3
Cohort 1: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)
|
Phase 1b: Cohort 2: LY2228820 + Gemcitabine + Carboplatin
n=2 participants at risk
Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3
Cohort 2: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)
|
Phase 2: Arm A: LY2228820 + Gemcitabine + Carboplatin
n=58 participants at risk
Arm A: LY2228820 200 mg orally every 12 hr. on Days 1-10
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3
Arm A: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)
|
Phase 2: Arm B: Placebo + Gemcitabine + Carboplatin
n=52 participants at risk
Arm B: Placebo orally every 12 hrs. on Days 1-10
Gemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10
Carboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3
Arm B: Placebo orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
83.3%
5/6 • Number of events 8 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
1/2 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
55.2%
32/58 • Number of events 91 • Up to 4.5 years
All participants who received at least one dose of drug.
|
48.1%
25/52 • Number of events 73 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.2%
3/58 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.8%
2/52 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
8.6%
5/58 • Number of events 8 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
83.3%
5/6 • Number of events 24 • Up to 4.5 years
All participants who received at least one dose of drug.
|
100.0%
2/2 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
44.8%
26/58 • Number of events 72 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
26/52 • Number of events 74 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
66.7%
4/6 • Number of events 9 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
29.3%
17/58 • Number of events 40 • Up to 4.5 years
All participants who received at least one dose of drug.
|
26.9%
14/52 • Number of events 47 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
10.3%
6/58 • Number of events 6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
15.4%
8/52 • Number of events 9 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Cardiac disorders
Sinus bradycardia
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
6.9%
4/58 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.8%
2/52 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Ear and labyrinth disorders
Vertigo
|
33.3%
2/6 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.8%
2/52 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Eye disorders
Glaucoma
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.2%
3/58 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.8%
2/52 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Eye disorders
Visual impairment
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
1/2 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
10.3%
6/58 • Number of events 6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
23.1%
12/52 • Number of events 13 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
20.7%
12/58 • Number of events 13 • Up to 4.5 years
All participants who received at least one dose of drug.
|
15.4%
8/52 • Number of events 9 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
8.6%
5/58 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
9.6%
5/52 • Number of events 7 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Anal incontinence
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
1/2 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
39.7%
23/58 • Number of events 31 • Up to 4.5 years
All participants who received at least one dose of drug.
|
42.3%
22/52 • Number of events 24 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
4/6 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
1/2 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
39.7%
23/58 • Number of events 40 • Up to 4.5 years
All participants who received at least one dose of drug.
|
26.9%
14/52 • Number of events 18 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
7.7%
4/52 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.2%
3/58 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
1/2 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.2%
3/58 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
7.7%
4/52 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Number of events 8 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
53.4%
31/58 • Number of events 39 • Up to 4.5 years
All participants who received at least one dose of drug.
|
63.5%
33/52 • Number of events 50 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
7.7%
4/52 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
2/6 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
15.5%
9/58 • Number of events 10 • Up to 4.5 years
All participants who received at least one dose of drug.
|
19.2%
10/52 • Number of events 11 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
29.3%
17/58 • Number of events 23 • Up to 4.5 years
All participants who received at least one dose of drug.
|
23.1%
12/52 • Number of events 12 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
General disorders
Chills
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
7.7%
4/52 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
General disorders
Fatigue
|
83.3%
5/6 • Number of events 11 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
69.0%
40/58 • Number of events 50 • Up to 4.5 years
All participants who received at least one dose of drug.
|
73.1%
38/52 • Number of events 48 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
12.1%
7/58 • Number of events 9 • Up to 4.5 years
All participants who received at least one dose of drug.
|
13.5%
7/52 • Number of events 8 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
13.8%
8/58 • Number of events 9 • Up to 4.5 years
All participants who received at least one dose of drug.
|
11.5%
6/52 • Number of events 7 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
8.6%
5/58 • Number of events 7 • Up to 4.5 years
All participants who received at least one dose of drug.
|
9.6%
5/52 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.2%
3/58 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Fungal skin infection
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
7.7%
4/52 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Sinusitis
|
50.0%
3/6 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.8%
2/52 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
8.6%
5/58 • Number of events 6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
13.8%
8/58 • Number of events 14 • Up to 4.5 years
All participants who received at least one dose of drug.
|
13.5%
7/52 • Number of events 10 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
33.3%
2/6 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
12.1%
7/58 • Number of events 8 • Up to 4.5 years
All participants who received at least one dose of drug.
|
11.5%
6/52 • Number of events 11 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
16.7%
1/6 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
1/2 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
43.1%
25/58 • Number of events 42 • Up to 4.5 years
All participants who received at least one dose of drug.
|
25.0%
13/52 • Number of events 35 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
3/6 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
29.3%
17/58 • Number of events 28 • Up to 4.5 years
All participants who received at least one dose of drug.
|
19.2%
10/52 • Number of events 22 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
15.5%
9/58 • Number of events 12 • Up to 4.5 years
All participants who received at least one dose of drug.
|
13.5%
7/52 • Number of events 7 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Investigations
Blood urea increased
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
1/2 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Investigations
Ejection fraction decreased
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
1/2 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
44.8%
26/58 • Number of events 76 • Up to 4.5 years
All participants who received at least one dose of drug.
|
55.8%
29/52 • Number of events 92 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
1/2 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
36.2%
21/58 • Number of events 53 • Up to 4.5 years
All participants who received at least one dose of drug.
|
38.5%
20/52 • Number of events 66 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Investigations
White blood cell count decreased
|
50.0%
3/6 • Number of events 12 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
34.5%
20/58 • Number of events 47 • Up to 4.5 years
All participants who received at least one dose of drug.
|
36.5%
19/52 • Number of events 55 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
3/6 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
24.1%
14/58 • Number of events 15 • Up to 4.5 years
All participants who received at least one dose of drug.
|
23.1%
12/52 • Number of events 13 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.8%
2/52 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
1/2 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
7.7%
4/52 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
2/6 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.2%
3/58 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
7.7%
4/52 • Number of events 7 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
1/2 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
12.1%
7/58 • Number of events 11 • Up to 4.5 years
All participants who received at least one dose of drug.
|
9.6%
5/52 • Number of events 14 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
10.3%
6/58 • Number of events 6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
9.6%
5/52 • Number of events 7 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
12.1%
7/58 • Number of events 10 • Up to 4.5 years
All participants who received at least one dose of drug.
|
23.1%
12/52 • Number of events 13 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
8.6%
5/58 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.2%
3/58 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
11.5%
6/52 • Number of events 6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
8.6%
5/58 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
9.6%
5/52 • Number of events 6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
6.9%
4/58 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
6.9%
4/58 • Number of events 7 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
20.7%
12/58 • Number of events 13 • Up to 4.5 years
All participants who received at least one dose of drug.
|
17.3%
9/52 • Number of events 9 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
8.6%
5/58 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
9.6%
5/52 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
17.2%
10/58 • Number of events 10 • Up to 4.5 years
All participants who received at least one dose of drug.
|
23.1%
12/52 • Number of events 20 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.8%
2/52 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
8.6%
5/58 • Number of events 6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.8%
2/52 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Nervous system disorders
Syncope
|
33.3%
2/6 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
10.3%
6/58 • Number of events 7 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Psychiatric disorders
Anxiety
|
33.3%
2/6 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
6.9%
4/58 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Psychiatric disorders
Insomnia
|
33.3%
2/6 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
1/2 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.2%
3/58 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
7.7%
4/52 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
7.7%
4/52 • Number of events 4 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
1/2 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
19.0%
11/58 • Number of events 11 • Up to 4.5 years
All participants who received at least one dose of drug.
|
23.1%
12/52 • Number of events 12 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
29.3%
17/58 • Number of events 20 • Up to 4.5 years
All participants who received at least one dose of drug.
|
17.3%
9/52 • Number of events 10 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.2%
3/58 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
1/2 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
8.6%
5/58 • Number of events 6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
1/2 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
12.1%
7/58 • Number of events 7 • Up to 4.5 years
All participants who received at least one dose of drug.
|
7.7%
4/52 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
2/6 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
12.1%
7/58 • Number of events 7 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.7%
1/58 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
1/2 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
17.2%
10/58 • Number of events 10 • Up to 4.5 years
All participants who received at least one dose of drug.
|
19.2%
10/52 • Number of events 10 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.2%
3/58 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.8%
2/52 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
12.1%
7/58 • Number of events 10 • Up to 4.5 years
All participants who received at least one dose of drug.
|
9.6%
5/52 • Number of events 7 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.2%
3/58 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.8%
2/52 • Number of events 2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
6.9%
4/58 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
5.8%
3/52 • Number of events 6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Social circumstances
Social problem
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
50.0%
1/2 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/52 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/58 • Up to 4.5 years
All participants who received at least one dose of drug.
|
7.7%
4/52 • Number of events 5 • Up to 4.5 years
All participants who received at least one dose of drug.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
0.00%
0/2 • Up to 4.5 years
All participants who received at least one dose of drug.
|
3.4%
2/58 • Number of events 3 • Up to 4.5 years
All participants who received at least one dose of drug.
|
1.9%
1/52 • Number of events 1 • Up to 4.5 years
All participants who received at least one dose of drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60