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Trial Outcomes & Findings for A Drug Interaction Study to Assess the Effect of LY317615 on the Metabolic Pathway of Warfarin (NCT NCT01388335)

NCT ID: NCT01388335

Last Updated: 2020-07-01

Results Overview

Cmax of S-Warfarin and R-Warfarin determined using Geometric Least Squares (LS) mean model that was estimated from a mixed-effects model with repeated measures (MMRM) that included treatment as a fixed effect (warfarin alone as reference, and warfarin with enzastaurin as test), participant as a random effect and random error term.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

13 participants

Primary outcome timeframe

Period 1 Day 1 (8 days) and Period 2 (19 up to 30 days): Predose, up to 96 hours postdose

Results posted on

2020-07-01

Participant Flow

Participant milestones

Participant milestones
Measure
Warfarin + Enzastaurin
Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout. Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15. Safety Extension Period: Participants were allowed to continue receiving 500 mg enzastaurin orally once daily alone until disease progression or other discontinuation criteria were met. Participants were on study for up to a total of 8 months (Period 1, Period 2 and Safety Extension Period).
Period 1
STARTED
13
Period 1
Received at Least 1 Dose of Study Drug
13
Period 1
COMPLETED
12
Period 1
NOT COMPLETED
1
Period 2
STARTED
12
Period 2
Received at Least 1 Dose of Study Drug
12
Period 2
COMPLETED
9
Period 2
NOT COMPLETED
3
Safety Extension
STARTED
7
Safety Extension
COMPLETED
0
Safety Extension
NOT COMPLETED
7

Reasons for withdrawal

Reasons for withdrawal
Measure
Warfarin + Enzastaurin
Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout. Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15. Safety Extension Period: Participants were allowed to continue receiving 500 mg enzastaurin orally once daily alone until disease progression or other discontinuation criteria were met. Participants were on study for up to a total of 8 months (Period 1, Period 2 and Safety Extension Period).
Period 1
Progressive Disease
1
Period 2
Progressive Disease
2
Period 2
Sponsor Decision
1
Safety Extension
Progressive Disease
7

Baseline Characteristics

A Drug Interaction Study to Assess the Effect of LY317615 on the Metabolic Pathway of Warfarin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Warfarin + Enzastaurin
n=13 Participants
Period 1 Day 1 (of an 8-day period): 5 milligram (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout. Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15. Safety Extension Period: Participants were allowed to continue receiving 500 mg enzastaurin orally once daily alone until disease progression or other discontinuation criteria were met. Participants were on study for up to a total of 8 months (Period 1, Period 2 and Safety Extension Period).
Age, Continuous
49.2 years
STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
Race/Ethnicity, Customized
White
13 Participants
n=5 Participants
Region of Enrollment
France
13 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Period 1 Day 1 (8 days) and Period 2 (19 up to 30 days): Predose, up to 96 hours postdose

Population: All enrolled participants who were assigned to a treatment, received at least 1 dose of study treatment.

Cmax of S-Warfarin and R-Warfarin determined using Geometric Least Squares (LS) mean model that was estimated from a mixed-effects model with repeated measures (MMRM) that included treatment as a fixed effect (warfarin alone as reference, and warfarin with enzastaurin as test), participant as a random effect and random error term.

Outcome measures

Outcome measures
Measure
Warfarin
n=13 Participants
Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout.
Warfarin + Enzastaurin
n=10 Participants
Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15.
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of S-Warfarin and R-Warfarin
S-Warfarin
245 nanograms/milliliter (ng/mL)
Interval 201.0 to 299.0
198 nanograms/milliliter (ng/mL)
Interval 161.0 to 245.0
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of S-Warfarin and R-Warfarin
R-Warfarin
253 nanograms/milliliter (ng/mL)
Interval 214.0 to 298.0
230 nanograms/milliliter (ng/mL)
Interval 194.0 to 273.0

PRIMARY outcome

Timeframe: Period 1 Day 1 (8 days) and Period 2 (19 up to 30 days): Predose, up to 96 hours postdose

Population: All enrolled participants who were assigned to a treatment and received at least 1 dose of study treatment and had S-warfarin and R-warfarin tmax values.

Outcome measures

Outcome measures
Measure
Warfarin
n=10 Participants
Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout.
Warfarin + Enzastaurin
n=10 Participants
Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15.
Pharmacokinetics: Time of Maximal Plasma Concentration (Tmax) of S-Warfarin and R-Warfarin
S-Warfarin
2.04 hours
Interval 0.5 to 6.0
4.50 hours
Interval 2.02 to 8.02
Pharmacokinetics: Time of Maximal Plasma Concentration (Tmax) of S-Warfarin and R-Warfarin
R-Warfarin
3.00 hours
Interval 0.5 to 12.0
7.00 hours
Interval 3.0 to 23.7

PRIMARY outcome

Timeframe: Period 1 Day 1 (8 days) and Period 2 (19 up to 30 days): Predose, up to 96 hours postdose

Population: All enrolled participants who were assigned to a treatment and received at least 1 dose of study treatment and had S-warfarin and R-warfarin AUC(0-∞) values.

AUC(0-∞) determined using Geometric Least Squares (LS) mean model that was estimated from a mixed-effects model with repeated measures (MMRM) that included treatment as a fixed effect (warfarin alone as reference, and warfarin with enzastaurin as test), participant as a random effect and random error term.

Outcome measures

Outcome measures
Measure
Warfarin
n=13 Participants
Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout.
Warfarin + Enzastaurin
n=9 Participants
Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15.
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] of S-Warfarin and R-Warfarin
S-Warfarin
8422 nanograms*hours/milliliter (ng*h/mL)
Interval 7112.0 to 9973.0
10754 nanograms*hours/milliliter (ng*h/mL)
Interval 9003.0 to 12846.0
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] of S-Warfarin and R-Warfarin
R-Warfarin
19122 nanograms*hours/milliliter (ng*h/mL)
Interval 16471.0 to 22200.0
24058 nanograms*hours/milliliter (ng*h/mL)
Interval 20350.0 to 28441.0

SECONDARY outcome

Timeframe: Period 2 Days 14 and 15 (19 up to 30 days): Predose, up to 24 hours postdose

Population: All enrolled participants who were assigned to a treatment and received at least 1 dose of study treatment and had Cmax,ss values.

Cmax at steady state (Cmax,ss) of enzastaurin, the principle metabolite (LSN326020), and the total analytes (enzastaurin, LSN326020, LSN485912 and LSN2406799) when enzastaurin is administered alone and with warfarin.

Outcome measures

Outcome measures
Measure
Warfarin
n=10 Participants
Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout.
Warfarin + Enzastaurin
n=10 Participants
Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15.
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) at Steady State of Enzastaurin, Its Principle Metabolites and Total Analyte
Enzastaurin
2170 nanomoles/liter (nmol/L)
Geometric Coefficient of Variation 93.3
2730 nanomoles/liter (nmol/L)
Geometric Coefficient of Variation 85.3
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) at Steady State of Enzastaurin, Its Principle Metabolites and Total Analyte
Metabolite LSN326020
769 nanomoles/liter (nmol/L)
Geometric Coefficient of Variation 56.5
872 nanomoles/liter (nmol/L)
Geometric Coefficient of Variation 51.8
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) at Steady State of Enzastaurin, Its Principle Metabolites and Total Analyte
Total Analytes
3600 nanomoles/liter (nmol/L)
Geometric Coefficient of Variation 82.1
4410 nanomoles/liter (nmol/L)
Geometric Coefficient of Variation 74.3

SECONDARY outcome

Timeframe: Period 2 Days 14 and 15 (19 up to 30 days): Predose, up to 24 hours postdose

Population: All enrolled participants who were assigned to a treatment and received at least 1 dose of study treatment who had enzastaurin, LSN326020 and total analyte tmax,ss values.

Tmax at steady state (tmax,ss) of enzastaurin, the principle metabolite (LSN326020), and the total analytes (enzastaurin, LSN326020, LSN485912 and LSN2406799) when enzastaurin is administered alone and with warfarin.

Outcome measures

Outcome measures
Measure
Warfarin
n=10 Participants
Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout.
Warfarin + Enzastaurin
n=10 Participants
Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15.
Pharmacokinetics: Time of Maximal Plasma Concentration (Tmax) of Enzastaurin, Its Principle Metabolites and Total Analyte
Enzastaurin
4.00 hours
Interval 0.0 to 8.08
4.00 hours
Interval 0.0 to 8.02
Pharmacokinetics: Time of Maximal Plasma Concentration (Tmax) of Enzastaurin, Its Principle Metabolites and Total Analyte
LSN326020
6.10 hours
Interval 2.0 to 8.08
8.01 hours
Interval 3.92 to 24.0
Pharmacokinetics: Time of Maximal Plasma Concentration (Tmax) of Enzastaurin, Its Principle Metabolites and Total Analyte
Total Analytes
4.04 hours
Interval 0.0 to 9.08
4.02 hours
Interval 2.0 to 24.0

SECONDARY outcome

Timeframe: Period 2 Days 14 and 15 (19 up to 30 days): Predose, up to 24 hours postdose

Population: All enrolled participants who were assigned to a treatment and received at least 1 dose of study treatment who had enzastaurin, LSN326020 and total analyte AUC,ss values .

AUCss of enzastaurin, the principle metabolite (LSN326020), and the total analytes (enzastaurin, LSN326020, LSN485912 and LSN2406799) when enzastaurin is administered alone and with warfarin.

Outcome measures

Outcome measures
Measure
Warfarin
n=10 Participants
Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout.
Warfarin + Enzastaurin
n=10 Participants
Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15.
Pharmacokinetics: Area Under Concentration-Time Curve Over a Dosing Interval at Steady State (AUCss) of Enzastaurin, Its Principle Metabolites and Total Analyte
Enzastaurin
35200 nanomoles*hour/liter (nmol*h/L)
Geometric Coefficient of Variation 124
44100 nanomoles*hour/liter (nmol*h/L)
Geometric Coefficient of Variation 115
Pharmacokinetics: Area Under Concentration-Time Curve Over a Dosing Interval at Steady State (AUCss) of Enzastaurin, Its Principle Metabolites and Total Analyte
LSN326020
16300 nanomoles*hour/liter (nmol*h/L)
Geometric Coefficient of Variation 64.0
19000 nanomoles*hour/liter (nmol*h/L)
Geometric Coefficient of Variation 53.2
Pharmacokinetics: Area Under Concentration-Time Curve Over a Dosing Interval at Steady State (AUCss) of Enzastaurin, Its Principle Metabolites and Total Analyte
Total Analytes
64800 nanomoles*hour/liter (nmol*h/L)
Geometric Coefficient of Variation 103
80500 nanomoles*hour/liter (nmol*h/L)
Geometric Coefficient of Variation 94.1

SECONDARY outcome

Timeframe: Period 2 Days 14 and 15 (19 up to 30 days): Predose, up to 24 hours post dose

Population: All enrolled participants who were assigned to a treatment and received at least 1 dose of study treatment who had enzastaurin, LSN326020 and total analyte Cav,ss values.

Cav,ss of enzastaurin, the principle metabolite (LSN326020), and the total analytes (enzastaurin, LSN326020, LSN485912 and LSN2406799) when enzastaurin is administered alone and with warfarin.

Outcome measures

Outcome measures
Measure
Warfarin
n=10 Participants
Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout.
Warfarin + Enzastaurin
n=10 Participants
Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15.
Pharmacokinetics: Average Concentration During a Dosing Interval Steady State (Cav,ss) of Enzastaurin, Its Principle Metabolites and Total Analyte
LSN326020
680 nanomole/liter (nmol/L)
Geometric Coefficient of Variation 64.0
790 nanomole/liter (nmol/L)
Geometric Coefficient of Variation 53.2
Pharmacokinetics: Average Concentration During a Dosing Interval Steady State (Cav,ss) of Enzastaurin, Its Principle Metabolites and Total Analyte
Enzastaurin
1470 nanomole/liter (nmol/L)
Geometric Coefficient of Variation 124
1840 nanomole/liter (nmol/L)
Geometric Coefficient of Variation 115
Pharmacokinetics: Average Concentration During a Dosing Interval Steady State (Cav,ss) of Enzastaurin, Its Principle Metabolites and Total Analyte
Total Analytes
2700 nanomole/liter (nmol/L)
Geometric Coefficient of Variation 103
3350 nanomole/liter (nmol/L)
Geometric Coefficient of Variation 94.1

SECONDARY outcome

Timeframe: Period 1 (8 days): Predose on Day 1, up to 96 hours postdose or Period 2 (19 up to 30 days): Predose on Day 15, up to 96 hours post warfarin dose

Population: All enrolled participants who were assigned to a treatment, received at least 1 dose of study treatment and had at least 1 evaluable INRmax warfarin or warfarin/enzastaurin value.

INRmax is the maximum INR over the time points after administration of warfarin alone. INR is the ratio of the actual prothrombin time over normal prothrombin time. Geometric Least Squares (LS) mean model was used that was estimated from a mixed-effects model with repeated measures (MMRM) that included treatment as a fixed effect, and participant as a random effect and a random term error.

Outcome measures

Outcome measures
Measure
Warfarin
n=13 Participants
Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout.
Warfarin + Enzastaurin
n=10 Participants
Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15.
Pharmacodynamics: Maximum International Normalised Ratio (INRmax) Following Warfarin Alone
1.18 ratio
Interval 1.03 to 1.35
1.09 ratio
Interval 0.95 to 1.26

SECONDARY outcome

Timeframe: Period 1 (8 days): Predose on Day 1, up to 96 hours postdose or Period 2 (19 up to 30 days): Predose on Day 15, up to 96 hours post warfarin dose

Population: All enrolled participants who were assigned to a treatment, received at least 1 dose of study treatment and at least 1 evaluable warfarin or warfarin plus enzastaurin AUC(INR) value.

AUC(INR) is the area under INR time curve over the time after administration of warfarin alone. INR is the ratio of actual prothrombin time over normal prothrombin time. Geometric Least Squares (LS) mean model was used that was estimated from a mixed-effects model with repeated measures (MMRM) that included treatment as a fixed effect, and participant as a random effect and a random term error.

Outcome measures

Outcome measures
Measure
Warfarin
n=13 Participants
Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout.
Warfarin + Enzastaurin
n=9 Participants
Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15.
Pharmacodynamics: Area Under International Normalised Ratio-time Curve AUC(INR) Following Warfarin Alone
97.24 ratio
Interval 93.52 to 101.11
95.45 ratio
Interval 91.47 to 99.59

SECONDARY outcome

Timeframe: Period 2 Day 15 (19 up to 30 days): Predose, up to 96 hours post warfarin dose

Population: All enrolled participants who were assigned to a treatment, received at least 1 dose of study treatment and had at least 1 evaluable INRmax warfarin and enzastaurin value.

INRmax is the maximum INR over the time points after administration of warfarin and enzastaurin. INR is the ratio of the actual prothrombin time over normal prothrombin time. Geometric Least Squares (LS) mean model was used that was estimated from a mixed-effects model with repeated measures (MMRM) that included predose measurement of INR in warfarin alone (Period 1) as a covariate, treatment as a fixed effect, participant as a random effect and a random error term. (See Outcome Measure 8 for statistical analysis comparing reporting groups Warfarin and Warfarin co-administered with Enzastaurin)

Outcome measures

Outcome measures
Measure
Warfarin
n=10 Participants
Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout.
Warfarin + Enzastaurin
Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15.
Pharmacodynamics: Maximum International Normalised Ratio (INRmax) Following Concomitant Administration of Warfarin and Enzastaurin
1.09 ratio
Interval 0.95 to 1.26
—

SECONDARY outcome

Timeframe: Period 2 Day 15 (19 up to 30 days): Predose, up to 96 hours post warfarin dose

Population: All enrolled participants who were assigned to a treatment, received at least 1 dose of study treatment and at least 1 evaluable AUC(INR) concomitant warfarin and enzastaurin value.

AUC(INR) is the area under INR time curve over the time after administration of warfarin and enzastaurin. INR is the ratio of actual prothrombin time over normal prothrombin time. Geometric Least Squares (LS) mean model was used that was estimated from a mixed-effects model with repeated measures (MMRM) that included predose measurement of INR in warfarin alone (Period 1) as a covariate, treatment as a fixed effect, participant as a random effect and a random error term. (See Outcome Measure 9 for statistical analysis comparing reporting groups Warfarin and Warfarin co-administered with Enzastaurin.)

Outcome measures

Outcome measures
Measure
Warfarin
n=9 Participants
Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout.
Warfarin + Enzastaurin
Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15.
Pharmacodynamics: Area Under International Normalised Ratio-Time Curve AUC(INR) Following Concomitant Administration of Warfarin and Enzastaurin
95.45 ratio
Interval 91.47 to 99.59
—

SECONDARY outcome

Timeframe: Period 2 Day 14 (19 up to 30 days): Predose and 4 hours postdose

Population: All enrolled participants who were assigned to a treatment, received at least 1 dose of study treatment and at least 1 evaluable INR enzastaurin result.

INR is the ratio of the actual prothrombin time over normal prothrombin time. Geometric Least Squares (LS) mean model was used that was estimated from timepoint (Period 1 Lead-in Day, 0 and 4 hours at Period 2, Day 14) as fixed effect, participant as a random effect and a random error term.

Outcome measures

Outcome measures
Measure
Warfarin
n=10 Participants
Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout.
Warfarin + Enzastaurin
Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15.
Pharmacodynamics: International Normalised Ratio (INR) Following Enzastaurin Alone
Period 2, Day 14, 0 Hours
0.97 ratio
Interval 0.92 to 1.02
—
Pharmacodynamics: International Normalised Ratio (INR) Following Enzastaurin Alone
Period 2, Day 14, 4 Hours
0.96 ratio
Interval 0.91 to 1.01
—

Adverse Events

Period 1

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Period 2, Prior to Warfarin Dose

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Period 2, Post Warfarin Dose

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Safety Extension

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Period 1
n=13 participants at risk
Period 1 Day 1 (of an 8-day period): 5 milligrams (mg) warfarin administered as a single oral dose. Period included at least a 7-day washout.
Period 2, Prior to Warfarin Dose
n=12 participants at risk
Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily up to Day 14.
Period 2, Post Warfarin Dose
n=10 participants at risk
Period 2 (19 up to 30 days): 500 mg enzastaurin administered orally once daily for at least 19 consecutive days and 5 mg warfarin administered as a single oral dose on Day 15. Enzastaurin administered up to 30 days total.
Safety Extension
n=7 participants at risk
Safety Extension: Participants were allowed to continue receiving 500 mg enzastaurin orally once daily alone until disease progression or other discontinuation criteria are met. Participants were on study for up to a total 8 months (Period 1, Period 2 and Safety Extension).
Blood and lymphatic system disorders
Anaemia
0.00%
0/13
0.00%
0/12
20.0%
2/10 • Number of events 3
28.6%
2/7 • Number of events 3
Eye disorders
Ocular icterus
0.00%
0/13
0.00%
0/12
0.00%
0/10
14.3%
1/7 • Number of events 1
Eye disorders
Vision blurred
0.00%
0/13
8.3%
1/12 • Number of events 1
0.00%
0/10
14.3%
1/7 • Number of events 2
Gastrointestinal disorders
Abdominal pain
7.7%
1/13 • Number of events 1
25.0%
3/12 • Number of events 3
10.0%
1/10 • Number of events 1
0.00%
0/7
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/13
0.00%
0/12
0.00%
0/10
14.3%
1/7 • Number of events 1
Gastrointestinal disorders
Constipation
15.4%
2/13 • Number of events 2
8.3%
1/12 • Number of events 1
0.00%
0/10
0.00%
0/7
Gastrointestinal disorders
Haemorrhoids
0.00%
0/13
0.00%
0/12
10.0%
1/10 • Number of events 1
0.00%
0/7
Gastrointestinal disorders
Nausea
0.00%
0/13
8.3%
1/12 • Number of events 1
0.00%
0/10
14.3%
1/7 • Number of events 1
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/13
0.00%
0/12
10.0%
1/10 • Number of events 1
0.00%
0/7
Gastrointestinal disorders
Vomiting
0.00%
0/13
8.3%
1/12 • Number of events 1
0.00%
0/10
28.6%
2/7 • Number of events 2
General disorders
Asthenia
7.7%
1/13 • Number of events 1
0.00%
0/12
0.00%
0/10
28.6%
2/7 • Number of events 4
General disorders
Fatigue
0.00%
0/13
0.00%
0/12
0.00%
0/10
14.3%
1/7 • Number of events 1
General disorders
Oedema peripheral
0.00%
0/13
8.3%
1/12 • Number of events 1
0.00%
0/10
0.00%
0/7
General disorders
Pyrexia
7.7%
1/13 • Number of events 1
0.00%
0/12
0.00%
0/10
14.3%
1/7 • Number of events 1
Hepatobiliary disorders
Hepatic function abnormal
7.7%
1/13 • Number of events 1
0.00%
0/12
0.00%
0/10
0.00%
0/7
Immune system disorders
Iodine allergy
0.00%
0/13
0.00%
0/12
0.00%
0/10
14.3%
1/7 • Number of events 1
Infections and infestations
Bronchitis
7.7%
1/13 • Number of events 1
8.3%
1/12 • Number of events 1
0.00%
0/10
0.00%
0/7
Infections and infestations
Eye infection
0.00%
0/13
0.00%
0/12
0.00%
0/10
14.3%
1/7 • Number of events 1
Infections and infestations
Postoperative wound infection
0.00%
0/13
0.00%
0/12
10.0%
1/10 • Number of events 1
0.00%
0/7
Infections and infestations
Vaginal infection
0.00%
0/7
0.00%
0/7
20.0%
1/5 • Number of events 1
0.00%
0/3
Injury, poisoning and procedural complications
Tooth avulsion
0.00%
0/13
0.00%
0/12
0.00%
0/10
14.3%
1/7 • Number of events 1
Investigations
Blood albumin decreased
0.00%
0/13
0.00%
0/12
10.0%
1/10 • Number of events 1
0.00%
0/7
Investigations
Electrocardiogram qt prolonged
0.00%
0/13
33.3%
4/12 • Number of events 5
0.00%
0/10
14.3%
1/7 • Number of events 1
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/13
8.3%
1/12 • Number of events 1
0.00%
0/10
28.6%
2/7 • Number of events 2
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/13
0.00%
0/12
10.0%
1/10 • Number of events 1
0.00%
0/7
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/13
0.00%
0/12
0.00%
0/10
14.3%
1/7 • Number of events 1
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/13
8.3%
1/12 • Number of events 1
0.00%
0/10
0.00%
0/7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/13
0.00%
0/12
0.00%
0/10
14.3%
1/7 • Number of events 1
Nervous system disorders
Headache
0.00%
0/13
8.3%
1/12 • Number of events 1
0.00%
0/10
14.3%
1/7 • Number of events 1
Nervous system disorders
Sciatica
0.00%
0/13
8.3%
1/12 • Number of events 1
10.0%
1/10 • Number of events 2
0.00%
0/7
Psychiatric disorders
Anxiety
0.00%
0/13
0.00%
0/12
10.0%
1/10 • Number of events 1
0.00%
0/7
Psychiatric disorders
Depression
0.00%
0/13
0.00%
0/12
0.00%
0/10
14.3%
1/7 • Number of events 1
Psychiatric disorders
Mood altered
0.00%
0/13
0.00%
0/12
0.00%
0/10
14.3%
1/7 • Number of events 1
Renal and urinary disorders
Chromaturia
0.00%
0/13
0.00%
0/12
10.0%
1/10 • Number of events 1
0.00%
0/7
Renal and urinary disorders
Hydronephrosis
0.00%
0/13
0.00%
0/12
10.0%
1/10 • Number of events 1
0.00%
0/7
Renal and urinary disorders
Renal failure acute
0.00%
0/13
8.3%
1/12 • Number of events 1
0.00%
0/10
0.00%
0/7
Reproductive system and breast disorders
Metrorrhagia
14.3%
1/7 • Number of events 1
0.00%
0/7
0.00%
0/5
0.00%
0/3
Reproductive system and breast disorders
Pelvic pain
0.00%
0/13
8.3%
1/12 • Number of events 1
10.0%
1/10 • Number of events 1
0.00%
0/7
Reproductive system and breast disorders
Vulvovaginal pruritus
14.3%
1/7 • Number of events 1
0.00%
0/7
0.00%
0/5
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Dyspnoea
7.7%
1/13 • Number of events 1
8.3%
1/12 • Number of events 1
0.00%
0/10
0.00%
0/7
Skin and subcutaneous tissue disorders
Hyperhidrosis
7.7%
1/13 • Number of events 1
0.00%
0/12
0.00%
0/10
0.00%
0/7
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/13
8.3%
1/12 • Number of events 1
0.00%
0/10
0.00%
0/7

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60