Trial Outcomes & Findings for A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer (NCT NCT02735980)
NCT ID: NCT02735980
Last Updated: 2020-03-17
Results Overview
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
133 participants
Primary outcome timeframe
Baseline to 10 months
Results posted on
2020-03-17
Participant Flow
Participant milestones
| Measure |
105 mg/m^2 Prexasertib (Platinum Sensitive Disease)
Intravenous (IV) prexasertib (LY2606368)administered on day 1 of every 14 day cycle
|
105 mg/m^2 Prexasertib (Platinum Resistant Disease)
IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
40 mg/m2 Prexasertib Exploratory Addendum
40 mg/m2 IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
|
|---|---|---|---|
|
Overall Study
STARTED
|
58
|
60
|
15
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
56
|
60
|
15
|
|
Overall Study
COMPLETED
|
48
|
49
|
14
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
1
|
Reasons for withdrawal
| Measure |
105 mg/m^2 Prexasertib (Platinum Sensitive Disease)
Intravenous (IV) prexasertib (LY2606368)administered on day 1 of every 14 day cycle
|
105 mg/m^2 Prexasertib (Platinum Resistant Disease)
IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
40 mg/m2 Prexasertib Exploratory Addendum
40 mg/m2 IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
1
|
|
Overall Study
Death
|
5
|
4
|
0
|
|
Overall Study
Physician Decision
|
3
|
1
|
0
|
|
Overall Study
Screen failure
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
Baseline Characteristics
N is number of participants with non-missing data.
Baseline characteristics by cohort
| Measure |
Prexasertib (Platinum Sensitive Disease)
n=58 Participants
Intravenous (IV) prexasertib (LY2606368)administered on day 1 of every 14 day cycle
|
Prexasertib (Platinum Resistant Disease)
n=60 Participants
IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib Exploratory Addendum (Platinum Sensitive Disease)
n=15 Participants
IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.17 years
STANDARD_DEVIATION 9.21 • n=58 Participants
|
61.45 years
STANDARD_DEVIATION 7.20 • n=60 Participants
|
61.67 years
STANDARD_DEVIATION 7.33 • n=15 Participants
|
62.66 years
STANDARD_DEVIATION 8.20 • n=133 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=58 Participants
|
10 Participants
n=60 Participants
|
4 Participants
n=15 Participants
|
37 Participants
n=133 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=58 Participants
|
50 Participants
n=60 Participants
|
11 Participants
n=15 Participants
|
96 Participants
n=133 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=58 Participants • N is number of participants with non-missing data.
|
0 Participants
n=59 Participants • N is number of participants with non-missing data.
|
0 Participants
n=15 Participants • N is number of participants with non-missing data.
|
0 Participants
n=132 Participants • N is number of participants with non-missing data.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=58 Participants • N is number of participants with non-missing data.
|
53 Participants
n=59 Participants • N is number of participants with non-missing data.
|
15 Participants
n=15 Participants • N is number of participants with non-missing data.
|
120 Participants
n=132 Participants • N is number of participants with non-missing data.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=58 Participants • N is number of participants with non-missing data.
|
6 Participants
n=59 Participants • N is number of participants with non-missing data.
|
0 Participants
n=15 Participants • N is number of participants with non-missing data.
|
12 Participants
n=132 Participants • N is number of participants with non-missing data.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants • N is number of participants with non-missing data.
|
0 Participants
n=56 Participants • N is number of participants with non-missing data.
|
0 Participants
n=15 Participants • N is number of participants with non-missing data.
|
0 Participants
n=125 Participants • N is number of participants with non-missing data.
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=54 Participants • N is number of participants with non-missing data.
|
8 Participants
n=56 Participants • N is number of participants with non-missing data.
|
2 Participants
n=15 Participants • N is number of participants with non-missing data.
|
12 Participants
n=125 Participants • N is number of participants with non-missing data.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants • N is number of participants with non-missing data.
|
0 Participants
n=56 Participants • N is number of participants with non-missing data.
|
0 Participants
n=15 Participants • N is number of participants with non-missing data.
|
0 Participants
n=125 Participants • N is number of participants with non-missing data.
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=54 Participants • N is number of participants with non-missing data.
|
1 Participants
n=56 Participants • N is number of participants with non-missing data.
|
0 Participants
n=15 Participants • N is number of participants with non-missing data.
|
3 Participants
n=125 Participants • N is number of participants with non-missing data.
|
|
Race (NIH/OMB)
White
|
50 Participants
n=54 Participants • N is number of participants with non-missing data.
|
47 Participants
n=56 Participants • N is number of participants with non-missing data.
|
13 Participants
n=15 Participants • N is number of participants with non-missing data.
|
110 Participants
n=125 Participants • N is number of participants with non-missing data.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants • N is number of participants with non-missing data.
|
0 Participants
n=56 Participants • N is number of participants with non-missing data.
|
0 Participants
n=15 Participants • N is number of participants with non-missing data.
|
0 Participants
n=125 Participants • N is number of participants with non-missing data.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants • N is number of participants with non-missing data.
|
0 Participants
n=56 Participants • N is number of participants with non-missing data.
|
0 Participants
n=15 Participants • N is number of participants with non-missing data.
|
0 Participants
n=125 Participants • N is number of participants with non-missing data.
|
|
Region of Enrollment
Greece
|
4 participants
n=58 Participants
|
4 participants
n=60 Participants
|
0 participants
n=15 Participants
|
8 participants
n=133 Participants
|
|
Region of Enrollment
Netherlands
|
5 participants
n=58 Participants
|
1 participants
n=60 Participants
|
0 participants
n=15 Participants
|
6 participants
n=133 Participants
|
|
Region of Enrollment
South Korea
|
0 participants
n=58 Participants
|
8 participants
n=60 Participants
|
0 participants
n=15 Participants
|
8 participants
n=133 Participants
|
|
Region of Enrollment
Turkey
|
6 participants
n=58 Participants
|
15 participants
n=60 Participants
|
0 participants
n=15 Participants
|
21 participants
n=133 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=58 Participants
|
12 participants
n=60 Participants
|
9 participants
n=15 Participants
|
45 participants
n=133 Participants
|
|
Region of Enrollment
Ukraine
|
1 participants
n=58 Participants
|
7 participants
n=60 Participants
|
0 participants
n=15 Participants
|
8 participants
n=133 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=58 Participants
|
0 participants
n=60 Participants
|
0 participants
n=15 Participants
|
2 participants
n=133 Participants
|
|
Region of Enrollment
France
|
7 participants
n=58 Participants
|
5 participants
n=60 Participants
|
0 participants
n=15 Participants
|
12 participants
n=133 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=58 Participants
|
2 participants
n=60 Participants
|
0 participants
n=15 Participants
|
2 participants
n=133 Participants
|
|
Region of Enrollment
Spain
|
9 participants
n=58 Participants
|
6 participants
n=60 Participants
|
6 participants
n=15 Participants
|
21 participants
n=133 Participants
|
PRIMARY outcome
Timeframe: Baseline to 10 monthsPopulation: All randomized participants who received at least 1 dose of study drug.
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions
Outcome measures
| Measure |
Prexasertib (Platinum Sensitive Disease)
n=58 Participants
Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib (Platinum Resistant Disease)
n=60 Participants
IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib Exploratory Addendum (Platinum Sensitive Disease)
n=15 Participants
IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
|
|---|---|---|---|
|
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
|
5.2 percentage of participants
Interval 0.7 to 9.6
|
0 percentage of participants
Interval 0.0 to 3.7
|
0 percentage of participants
Interval 0.0 to 14.8
|
SECONDARY outcome
Timeframe: Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytimePopulation: All randomized participants who received at least 1 dose of study drug and had evaluable PK parameters. Cohort 1 and Cohort 2 received the same dose and were combined per protocol.
Pharmacokinetics(PK): Maximum Concentration of Prexasertib. The same dose was administered to Cohort 1 and Cohort 2 and were combined for analysis.
Outcome measures
| Measure |
Prexasertib (Platinum Sensitive Disease)
n=99 Participants
Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib (Platinum Resistant Disease)
IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib Exploratory Addendum (Platinum Sensitive Disease)
IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
|
|---|---|---|---|
|
Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2
Cycle 1
|
722 nanogram per milliliter
Geometric Coefficient of Variation 64
|
—
|
—
|
|
Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2
Cycle 3
|
735 nanogram per milliliter
Geometric Coefficient of Variation 71
|
—
|
—
|
|
Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2
Cycle 5
|
732 nanogram per milliliter
Geometric Coefficient of Variation 69
|
—
|
—
|
|
Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2
Cycle 7
|
1230 nanogram per milliliter
Geometric Coefficient of Variation 22
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytimePopulation: Al randomized participants with at least 1 dose of study drug, received 40 mg/m\^2 and had evaluable PK parameters.
Pharmacokinetics(PK): Maximum Concentration of Prexasertib
Outcome measures
| Measure |
Prexasertib (Platinum Sensitive Disease)
n=15 Participants
Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib (Platinum Resistant Disease)
IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib Exploratory Addendum (Platinum Sensitive Disease)
IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
|
|---|---|---|---|
|
Pharmacokinetics(PK): Maximum Concentration of Prexasertib Cohort 3 (40 mg/m^2, Protocol Addenda)
|
227 nanograms per milliliter
Geometric Coefficient of Variation 68
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytimePopulation: All participants in Part A1 that received at least 1 dose of study drug and had evaluable PK data.
Pharmacokinetics: Area Under the Concentration Curve of Prexasertib
Outcome measures
| Measure |
Prexasertib (Platinum Sensitive Disease)
n=56 Participants
Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib (Platinum Resistant Disease)
n=60 Participants
IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib Exploratory Addendum (Platinum Sensitive Disease)
n=15 Participants
IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
|
|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve of Prexasertib
|
126 mg*h/mL
Geometric Coefficient of Variation 154
|
1190 mg*h/mL
Geometric Coefficient of Variation 95
|
1840 mg*h/mL
Geometric Coefficient of Variation 35
|
SECONDARY outcome
Timeframe: Baseline through Disease Progression or Death from Any Cause to 28 monthsPopulation: All randomized participants who received at least 1 dose of study drug.
Disease control rate (DCR) is defined as the percentage of participants achieving a best overall response of CR, PR, or SD as determined by RECIST 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to \<10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters; SD is defined as neither sufficient shrinking to qualify as PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Prexasertib (Platinum Sensitive Disease)
n=58 Participants
Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib (Platinum Resistant Disease)
n=60 Participants
IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib Exploratory Addendum (Platinum Sensitive Disease)
n=15 Participants
IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
|
|---|---|---|---|
|
Disease Control Rate: Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD)
|
31 percentage of participants
Interval 12.6 to 31.4
|
20.0 percentage of participants
Interval 6.6 to 20.6
|
40.0 percentage of participants
Interval 10.2 to 48.4
|
SECONDARY outcome
Timeframe: Baseline to Disease Progression or Death (up to 9 months)Population: All randomized participants. 4 participants were censored from Prexasertib Cohort 1 and 1 participant from Prexasertib Cohort 3.
PFS defined as the from randomization date to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Outcome measures
| Measure |
Prexasertib (Platinum Sensitive Disease)
n=58 Participants
Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib (Platinum Resistant Disease)
n=60 Participants
IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib Exploratory Addendum (Platinum Sensitive Disease)
n=15 Participants
IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
|
|---|---|---|---|
|
Progression-Free Survival (PFS)
|
1.41 months
Interval 1.31 to 1.64
|
1.36 months
Interval 1.25 to 1.45
|
1.58 months
Interval 1.38 to 3.12
|
SECONDARY outcome
Timeframe: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause up to 9 monthsPopulation: Analysis was not performed due to only 3 responders in Cohort 1, no in Cohort 2 or 3. Individual data for Cohort 1 is presented.
DoR the time from the date of an objective response until Progressive Disease (PD): was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Outcome measures
| Measure |
Prexasertib (Platinum Sensitive Disease)
n=58 Participants
Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib (Platinum Resistant Disease)
n=60 Participants
IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib Exploratory Addendum (Platinum Sensitive Disease)
n=15 Participants
IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
|
|---|---|---|---|
|
Duration of Response (DoR)
|
NA days
Individual DoR is 127, 172 and 153 days for 3 responders
|
NA days
No responders
|
NA days
No responders
|
SECONDARY outcome
Timeframe: Baseline up to 28 monthsPopulation: All randomized participants. 8 participants were censored from Cohort 1, 5 participants were censored from Cohort 2 and 4 participants censored from Cohort 3.
OS defined as from randomization date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
Outcome measures
| Measure |
Prexasertib (Platinum Sensitive Disease)
n=58 Participants
Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib (Platinum Resistant Disease)
n=60 Participants
IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib Exploratory Addendum (Platinum Sensitive Disease)
n=15 Participants
IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
|
|---|---|---|---|
|
Overall Survival (OS)
|
5.42 months
Interval 3.75 to 8.51
|
3.15 months
Interval 2.27 to 5.52
|
7.26 months
Interval 2.0 to 9.49
|
SECONDARY outcome
Timeframe: Baseline up to 9 monthsPopulation: All participants in Cohort 1 and Cohort 2. Cohort 3 was added by protocol addendum and data were not collected with non missing baseline and post baseline scores.
LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. The LCSS total score was defined as the mean of the 9 items of the scale, each scored between 0 (for best outcome) to 100 (for worst outcome).
Outcome measures
| Measure |
Prexasertib (Platinum Sensitive Disease)
n=58 Participants
Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib (Platinum Resistant Disease)
n=60 Participants
IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib Exploratory Addendum (Platinum Sensitive Disease)
IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
|
|---|---|---|---|
|
Change From Baseline in Lung Cancer Symptom Scale Score (LCSS)
|
-2.8 units on a scale
Standard Deviation 12.3
|
-4.0 units on a scale
Standard Deviation 10.2
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 9 monthsPopulation: All participants in Cohort 1 and Cohort 2. Cohort 3 was added by protocol addendum and data were not collected with non missing baseline and post baseline scores.
ABSI was the mean score for the six major lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis and pain), each scored between 0 (for best outcome) to 100 (for worst outcome).
Outcome measures
| Measure |
Prexasertib (Platinum Sensitive Disease)
n=58 Participants
Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib (Platinum Resistant Disease)
n=60 Participants
IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
Prexasertib Exploratory Addendum (Platinum Sensitive Disease)
IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
|
|---|---|---|---|
|
Change From Baseline on the Average Symptom Burden Index (ASBI)
|
-3.0 units on a scale
Standard Deviation 11.9
|
-4.4 units on a scale
Standard Deviation 11.1
|
—
|
Adverse Events
105 mg/m^2 Prexasertib (Platinum Sensitive Disease)
Serious events: 21 serious events
Other events: 56 other events
Deaths: 10 deaths
105 mg/m^2 Prexasertib (Platinum Resistant Disease)
Serious events: 16 serious events
Other events: 59 other events
Deaths: 7 deaths
40 mg/m2 Prexasertib Exploratory Addendum
Serious events: 6 serious events
Other events: 15 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
105 mg/m^2 Prexasertib (Platinum Sensitive Disease)
n=56 participants at risk
Intravenous (IV) prexasertib (LY2606368)administered on day 1 of every 14 day cycle
|
105 mg/m^2 Prexasertib (Platinum Resistant Disease)
n=60 participants at risk
IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
40 mg/m2 Prexasertib Exploratory Addendum
n=15 participants at risk
IV 40 mg/m2 prexasertib (LY2606368) IV administered on Days 1, 2 and 3 of a 14-day cycle
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
3.3%
2/60 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
8/56 • Number of events 9 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
13.3%
2/15 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.6%
2/56 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
3.6%
2/56 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
3.6%
2/56 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Escherichia bacteraemia
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Parainfluenzae virus infection
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
8.9%
5/56 • Number of events 9 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
13.3%
2/15 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia haemophilus
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
5.4%
3/56 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram qt prolonged
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
4/60 • Number of events 7 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.6%
2/56 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
1.8%
1/56 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Lethargy
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
3.6%
2/56 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
4/60 • Number of events 4 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
3.3%
2/60 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
1.8%
1/56 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
105 mg/m^2 Prexasertib (Platinum Sensitive Disease)
n=56 participants at risk
Intravenous (IV) prexasertib (LY2606368)administered on day 1 of every 14 day cycle
|
105 mg/m^2 Prexasertib (Platinum Resistant Disease)
n=60 participants at risk
IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
|
40 mg/m2 Prexasertib Exploratory Addendum
n=15 participants at risk
IV 40 mg/m2 prexasertib (LY2606368) IV administered on Days 1, 2 and 3 of a 14-day cycle
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
28/56 • Number of events 46 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
33.3%
20/60 • Number of events 36 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
60.0%
9/15 • Number of events 30 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.9%
5/56 • Number of events 5 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.4%
3/56 • Number of events 4 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
10.0%
6/60 • Number of events 11 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
32.1%
18/56 • Number of events 30 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
30.0%
18/60 • Number of events 39 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
26.7%
4/15 • Number of events 11 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
23.2%
13/56 • Number of events 27 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
15.0%
9/60 • Number of events 27 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
26.7%
4/15 • Number of events 11 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eye haematoma
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
3.3%
2/60 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
7/56 • Number of events 9 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
10.0%
6/60 • Number of events 6 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.9%
10/56 • Number of events 14 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
8.3%
5/60 • Number of events 12 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
20.0%
3/15 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
26.8%
15/56 • Number of events 17 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
20.0%
12/60 • Number of events 16 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
20.0%
3/15 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
5.4%
3/56 • Number of events 4 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
3.3%
2/60 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
20.0%
3/15 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
8/56 • Number of events 11 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
11.7%
7/60 • Number of events 11 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
20.0%
3/15 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
14.3%
8/56 • Number of events 9 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
8.3%
5/60 • Number of events 7 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
13.3%
2/15 • Number of events 9 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Catheter site pain
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
28.6%
16/56 • Number of events 25 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
30.0%
18/60 • Number of events 25 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
40.0%
6/15 • Number of events 8 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
13.3%
2/15 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
12.5%
7/56 • Number of events 8 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
8.3%
5/60 • Number of events 5 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
7.1%
4/56 • Number of events 5 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
7.1%
4/56 • Number of events 4 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
8.3%
5/60 • Number of events 7 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
20.0%
3/15 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
3.6%
2/56 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tooth infection
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
5.4%
3/56 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
3.3%
2/60 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
3.6%
2/56 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
4/60 • Number of events 8 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
13.3%
2/15 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
5.4%
3/56 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
8.3%
5/60 • Number of events 5 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
13.3%
2/15 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
1.8%
1/56 • Number of events 4 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
4/60 • Number of events 5 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.6%
2/56 • Number of events 5 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
8.3%
5/60 • Number of events 6 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Lipase increased
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
12.5%
7/56 • Number of events 18 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
10.0%
6/60 • Number of events 16 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
20.0%
3/15 • Number of events 5 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
41.1%
23/56 • Number of events 62 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
43.3%
26/60 • Number of events 68 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
46.7%
7/15 • Number of events 38 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
32.1%
18/56 • Number of events 49 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
38.3%
23/60 • Number of events 44 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
60.0%
9/15 • Number of events 36 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
8.9%
5/56 • Number of events 5 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
5.0%
3/60 • Number of events 6 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
White blood cell count decreased
|
25.0%
14/56 • Number of events 34 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
30.0%
18/60 • Number of events 59 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
33.3%
5/15 • Number of events 9 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.2%
13/56 • Number of events 18 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
23.3%
14/60 • Number of events 20 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
40.0%
6/15 • Number of events 7 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.7%
6/56 • Number of events 7 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
3.3%
2/60 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.4%
3/56 • Number of events 4 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
3.3%
2/60 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
4/56 • Number of events 4 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
5.0%
3/60 • Number of events 7 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
13.3%
2/15 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.4%
3/56 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
3.3%
2/60 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.1%
4/56 • Number of events 5 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
3.3%
2/60 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 5 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
5.0%
3/60 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
13.3%
2/15 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
7/56 • Number of events 7 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
8.3%
5/60 • Number of events 6 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.4%
3/56 • Number of events 5 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
5.0%
3/60 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
13.3%
2/15 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.4%
3/56 • Number of events 4 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
4/60 • Number of events 5 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
5.4%
3/56 • Number of events 5 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
13.3%
2/15 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
5.4%
3/56 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
8.3%
5/60 • Number of events 6 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
3.6%
2/56 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
5.0%
3/60 • Number of events 3 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/56 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/60 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
16/56 • Number of events 21 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
15.0%
9/60 • Number of events 9 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.6%
11/56 • Number of events 13 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
21.7%
13/60 • Number of events 14 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
13.3%
2/15 • Number of events 2 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
4/60 • Number of events 4 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
1.8%
1/56 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
1.7%
1/60 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1 • up to 28 months
All randomized participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60