Trial Outcomes & Findings for Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer (NCT NCT00415636)
NCT ID: NCT00415636
Last Updated: 2018-10-19
Results Overview
Summary tables of serious AEs (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
baseline up to 24 months
Results posted on
2018-10-19
Participant Flow
Participant milestones
| Measure |
LY2603618 40 mg/m^2 (4.5-hour Infusion)
LY2603618 40 milligrams per square meter (mg/m\^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed.
|
LY2603618 40 mg/m^2 (1-hour Infusion)
Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m\^2 \[4.5-hour infusion\]), LY2603618 40 mg/m\^2 dose in Cohort 2 (LY2603618 40 mg/m\^2 \[1-hour infusion\]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed.
|
LY2603618 70 mg/m^2
Beginning with Cohort 3 (LY2603618 70 mg/m\^2), dose modifications were allowed. LY2603618 70 mg/m\^2 was administered over the course of 1 hour.
|
LY2603618 105 mg/m^2
LY2603618 105 mg/m\^2 administered over the duration of 1 hour.
|
LY2603618 150 mg/m^2
LY2603618 150 mg/m\^2 administered over the duration of 1 hour.
|
LY2603618 195 mg/m^2
LY2603618 195 mg/m\^2 administered over the duration of 1 hour.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
13
|
6
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
2
|
7
|
4
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
6
|
2
|
2
|
Reasons for withdrawal
| Measure |
LY2603618 40 mg/m^2 (4.5-hour Infusion)
LY2603618 40 milligrams per square meter (mg/m\^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed.
|
LY2603618 40 mg/m^2 (1-hour Infusion)
Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m\^2 \[4.5-hour infusion\]), LY2603618 40 mg/m\^2 dose in Cohort 2 (LY2603618 40 mg/m\^2 \[1-hour infusion\]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed.
|
LY2603618 70 mg/m^2
Beginning with Cohort 3 (LY2603618 70 mg/m\^2), dose modifications were allowed. LY2603618 70 mg/m\^2 was administered over the course of 1 hour.
|
LY2603618 105 mg/m^2
LY2603618 105 mg/m\^2 administered over the duration of 1 hour.
|
LY2603618 150 mg/m^2
LY2603618 150 mg/m\^2 administered over the duration of 1 hour.
|
LY2603618 195 mg/m^2
LY2603618 195 mg/m\^2 administered over the duration of 1 hour.
|
|---|---|---|---|---|---|---|
|
Overall Study
Symptomatic deterioration
|
1
|
0
|
1
|
2
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Disease progression
|
0
|
0
|
0
|
3
|
0
|
1
|
Baseline Characteristics
Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer
Baseline characteristics by cohort
| Measure |
LY2603618 40 mg/m^2 (4.5-hour Infusion)
n=3 Participants
LY2603618 40 milligrams per square meter (mg/m\^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed.
|
LY2603618 40 mg/m^2 (1-hour Infusion)
n=3 Participants
Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m\^2 \[4.5-hour infusion\]), LY2603618 40 mg/m\^2 dose in Cohort 2 (LY2603618 40 mg/m\^2 \[1-hour infusion\]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed.
|
LY2603618 70 mg/m^2
n=3 Participants
Beginning with Cohort 3 (LY2603618 70 mg/m\^2), dose modifications were allowed. LY2603618 70 mg/m\^2 was administered over the course of 1 hour.
|
LY2603618 105 mg/m^2
n=13 Participants
LY2603618 105 mg/m\^2 administered over the duration of 1 hour.
|
LY2603618 150 mg/m^2
n=6 Participants
LY2603618 150 mg/m\^2 administered over the duration of 1 hour.
|
LY2603618 195 mg/m^2
n=3 Participants
LY2603618 195 mg/m\^2 administered over the duration of 1 hour.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Primary Cancer Type
Breast
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
|
Primary Cancer Type
Non-small Cell Lung
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 6.24 • n=99 Participants
|
58.0 years
STANDARD_DEVIATION 10.54 • n=107 Participants
|
48.3 years
STANDARD_DEVIATION 16.07 • n=206 Participants
|
60.6 years
STANDARD_DEVIATION 9.95 • n=7 Participants
|
63.5 years
STANDARD_DEVIATION 11.04 • n=31 Participants
|
55.7 years
STANDARD_DEVIATION 18.77 • n=30 Participants
|
58.1 years
STANDARD_DEVIATION 11.73 • n=3 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
15 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
16 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
30 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
28 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
31 Participants
n=3 Participants
|
|
Primary Cancer Type
Pancreatic
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
|
Primary Cancer Type
Other
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
18 Participants
n=3 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Rating at Screening
ECOG Rating 0
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Rating at Screening
ECOG Rating 1
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
23 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: baseline up to 24 monthsPopulation: The safety population was comprised of all participants who received any amount of LY2603618.
Summary tables of serious AEs (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.
Outcome measures
| Measure |
LY2603618 40 mg/m^2 (4.5-hour Infusion)
n=3 Participants
4.5-hour intravenous (IV) infusion of IC83/LY2603618 40 mg/m\^2
|
LY2603618 40 mg/m^2 (1-hour Infusion)
n=3 Participants
1.0-hour IV infusion of IC83/LY2603618 40 mg/m\^2
|
LY2603618 70 mg/m^2
n=3 Participants
1.0-hour IV infusion of IC83/LY2603618 70 mg/m\^2
|
LY2603618 105 mg/m^2
n=13 Participants
1.0-hour IV infusion of IC83/LY2603618 105 mg/m\^2
|
LY2603618 150 mg/m^2
n=6 Participants
1.0-hour IV infusion of IC83/LY2603618 150 mg/m\^2
|
LY2603618 195 mg/m^2
n=3 Participants
1.0-hour IV infusion of IC83/LY2603618 195 mg/m\^2
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Other Non-Serious Adverse Events (AEs)
|
3 Participants
|
3 Participants
|
3 Participants
|
13 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs)
Serious Adverse Events (SAEs)
|
1 Participants
|
0 Participants
|
2 Participants
|
8 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 9 of Cycle 1Population: Pharmacokinetic (PK) analyses were conducted for individual participants who received at least 1 dose of study drug and had PK samples collected.
Cmax was estimated from the plasma concentration data of LY2603618 versus time profiles.
Outcome measures
| Measure |
LY2603618 40 mg/m^2 (4.5-hour Infusion)
n=3 Participants
4.5-hour intravenous (IV) infusion of IC83/LY2603618 40 mg/m\^2
|
LY2603618 40 mg/m^2 (1-hour Infusion)
n=3 Participants
1.0-hour IV infusion of IC83/LY2603618 40 mg/m\^2
|
LY2603618 70 mg/m^2
n=3 Participants
1.0-hour IV infusion of IC83/LY2603618 70 mg/m\^2
|
LY2603618 105 mg/m^2
n=13 Participants
1.0-hour IV infusion of IC83/LY2603618 105 mg/m\^2
|
LY2603618 150 mg/m^2
n=6 Participants
1.0-hour IV infusion of IC83/LY2603618 150 mg/m\^2
|
LY2603618 195 mg/m^2
n=3 Participants
1.0-hour IV infusion of IC83/LY2603618 195 mg/m\^2
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618
Day 1
|
578 nanograms per millimeter (ng/mL)
Standard Deviation 181
|
1560 nanograms per millimeter (ng/mL)
Standard Deviation 358
|
2310 nanograms per millimeter (ng/mL)
Standard Deviation 1330
|
4220 nanograms per millimeter (ng/mL)
Standard Deviation 1370
|
4230 nanograms per millimeter (ng/mL)
Standard Deviation 1370
|
6840 nanograms per millimeter (ng/mL)
Standard Deviation 839
|
|
Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618
Day 9
|
614 nanograms per millimeter (ng/mL)
Standard Deviation 169
|
2010 nanograms per millimeter (ng/mL)
Standard Deviation 581
|
2510 nanograms per millimeter (ng/mL)
Standard Deviation 942
|
4540 nanograms per millimeter (ng/mL)
Standard Deviation 2270
|
3560 nanograms per millimeter (ng/mL)
Standard Deviation 1320
|
7580 nanograms per millimeter (ng/mL)
Standard Deviation 1260
|
SECONDARY outcome
Timeframe: Day 1 and Day 9 of Cycle 1Population: Pharmacokinetic (PK) analyses were conducted for individual participants who received at least 1 dose of study drug and had PK samples collected.
AUC\[0-∞\] was calculated from the plasma concentration data of LY2603618 versus time profiles.
Outcome measures
| Measure |
LY2603618 40 mg/m^2 (4.5-hour Infusion)
n=3 Participants
4.5-hour intravenous (IV) infusion of IC83/LY2603618 40 mg/m\^2
|
LY2603618 40 mg/m^2 (1-hour Infusion)
n=3 Participants
1.0-hour IV infusion of IC83/LY2603618 40 mg/m\^2
|
LY2603618 70 mg/m^2
n=3 Participants
1.0-hour IV infusion of IC83/LY2603618 70 mg/m\^2
|
LY2603618 105 mg/m^2
n=13 Participants
1.0-hour IV infusion of IC83/LY2603618 105 mg/m\^2
|
LY2603618 150 mg/m^2
n=6 Participants
1.0-hour IV infusion of IC83/LY2603618 150 mg/m\^2
|
LY2603618 195 mg/m^2
n=3 Participants
1.0-hour IV infusion of IC83/LY2603618 195 mg/m\^2
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞])
Day 9
|
7540 nanograms*hour per milliliter (ng*h/mL)
Standard Deviation 1790
|
11000 nanograms*hour per milliliter (ng*h/mL)
Standard Deviation 2550
|
10900 nanograms*hour per milliliter (ng*h/mL)
Standard Deviation 6280
|
52000 nanograms*hour per milliliter (ng*h/mL)
Standard Deviation 33900
|
55000 nanograms*hour per milliliter (ng*h/mL)
Standard Deviation 45000
|
119000 nanograms*hour per milliliter (ng*h/mL)
Standard Deviation 30300
|
|
Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞])
Day 1
|
7580 nanograms*hour per milliliter (ng*h/mL)
Standard Deviation 790
|
10300 nanograms*hour per milliliter (ng*h/mL)
Standard Deviation 2810
|
9510 nanograms*hour per milliliter (ng*h/mL)
Standard Deviation 5560
|
76400 nanograms*hour per milliliter (ng*h/mL)
Standard Deviation 65000
|
61900 nanograms*hour per milliliter (ng*h/mL)
Standard Deviation 53300
|
122000 nanograms*hour per milliliter (ng*h/mL)
Standard Deviation 42000
|
SECONDARY outcome
Timeframe: baseline up to 24 monthsPopulation: A modified intent-to-treat population (mITT) was used to summarize the data for tumor response. The mITT population consisted of all participants who received any dose of study drug and had at least 1 nonmissing postbaseline tumor response assessment.
Percentage of participants with tumor response (best confirmed overall response) assessed as complete response (CR) or partial response (PR) to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD) =small changes that do not meet above criteria. Best Overall Response (%)=number of participants with CR+PR/number of participants in treatment arm \* 100.
Outcome measures
| Measure |
LY2603618 40 mg/m^2 (4.5-hour Infusion)
n=2 Participants
4.5-hour intravenous (IV) infusion of IC83/LY2603618 40 mg/m\^2
|
LY2603618 40 mg/m^2 (1-hour Infusion)
n=3 Participants
1.0-hour IV infusion of IC83/LY2603618 40 mg/m\^2
|
LY2603618 70 mg/m^2
n=2 Participants
1.0-hour IV infusion of IC83/LY2603618 70 mg/m\^2
|
LY2603618 105 mg/m^2
n=10 Participants
1.0-hour IV infusion of IC83/LY2603618 105 mg/m\^2
|
LY2603618 150 mg/m^2
n=4 Participants
1.0-hour IV infusion of IC83/LY2603618 150 mg/m\^2
|
LY2603618 195 mg/m^2
n=2 Participants
1.0-hour IV infusion of IC83/LY2603618 195 mg/m\^2
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Best Overall Response
Complete Response (CR)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Best Overall Response
Partial Response (PR)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
10 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Best Overall Response
Stable Disease (SD)
|
0 Percentage of participants
|
66.7 Percentage of participants
|
50 Percentage of participants
|
20 Percentage of participants
|
75 Percentage of participants
|
50 Percentage of participants
|
|
Percentage of Participants With Best Overall Response
Progressive Disease (PD)
|
100 Percentage of participants
|
33.3 Percentage of participants
|
50 Percentage of participants
|
70 Percentage of participants
|
25 Percentage of participants
|
50 Percentage of participants
|
|
Percentage of Participants With Best Overall Response
Best Overall Response (CR + PR)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
10 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Best Overall Response
Not Determined
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
LY2603618 40 mg/m^2 (4.5-hour Infusion)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
LY2603618 40 mg/m^2 (1-hour Infusion)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LY2603618 70 mg/m^2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
LY2603618 105 mg/m^2
Serious events: 8 serious events
Other events: 13 other events
Deaths: 0 deaths
LY2603618 150 mg/m^2
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
LY2603618 195 mg/m^2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY2603618 40 mg/m^2 (4.5-hour Infusion)
n=3 participants at risk
LY2603618 40 milligrams per square meter (mg/m\^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed.
|
LY2603618 40 mg/m^2 (1-hour Infusion)
n=3 participants at risk
Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m\^2 \[4.5-hour infusion\]), LY2603618 40 mg/m\^2 dose in Cohort 2 (LY2603618 40 mg/m\^2 \[1-hour infusion\]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed.
|
LY2603618 70 mg/m^2
n=3 participants at risk
Beginning with Cohort 3 (LY2603618 70 mg/m\^2), dose modifications were allowed. LY2603618 70 mg/m\^2 was administered over the course of 1 hour.
|
LY2603618 105 mg/m^2
n=13 participants at risk
LY2603618 105 mg/m\^2 administered over the duration of 1 hour.
|
LY2603618 150 mg/m^2
n=6 participants at risk
LY2603618 150 mg/m\^2 administered over the duration of 1 hour.
|
LY2603618 195 mg/m^2
n=3 participants at risk
LY2603618 195 mg/m\^2 administered over the duration of 1 hour.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
66.7%
2/3 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 2
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
|
General disorders
Fatigue
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
General disorders
Infusion related reaction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Nervous system disorders
Convulsion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
Other adverse events
| Measure |
LY2603618 40 mg/m^2 (4.5-hour Infusion)
n=3 participants at risk
LY2603618 40 milligrams per square meter (mg/m\^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed.
|
LY2603618 40 mg/m^2 (1-hour Infusion)
n=3 participants at risk
Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m\^2 \[4.5-hour infusion\]), LY2603618 40 mg/m\^2 dose in Cohort 2 (LY2603618 40 mg/m\^2 \[1-hour infusion\]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed.
|
LY2603618 70 mg/m^2
n=3 participants at risk
Beginning with Cohort 3 (LY2603618 70 mg/m\^2), dose modifications were allowed. LY2603618 70 mg/m\^2 was administered over the course of 1 hour.
|
LY2603618 105 mg/m^2
n=13 participants at risk
LY2603618 105 mg/m\^2 administered over the duration of 1 hour.
|
LY2603618 150 mg/m^2
n=6 participants at risk
LY2603618 150 mg/m\^2 administered over the duration of 1 hour.
|
LY2603618 195 mg/m^2
n=3 participants at risk
LY2603618 195 mg/m\^2 administered over the duration of 1 hour.
|
|---|---|---|---|---|---|---|
|
General disorders
Mucosal inflammation
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
|
General disorders
Oedema peripheral
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
30.8%
4/13 • Number of events 6
|
50.0%
3/6 • Number of events 3
|
0.00%
0/3
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
30.8%
4/13 • Number of events 5
|
33.3%
2/6 • Number of events 3
|
0.00%
0/3
|
|
General disorders
Tenderness
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
General disorders
Thirst
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
15.4%
2/13 • Number of events 5
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 4
|
7.7%
1/13 • Number of events 1
|
50.0%
3/6 • Number of events 5
|
33.3%
1/3 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
38.5%
5/13 • Number of events 6
|
50.0%
3/6 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
7.7%
1/13 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
66.7%
2/3 • Number of events 4
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Ear and labyrinth disorders
Ear pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Eye disorders
Conjunctival pallor
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Eye disorders
Photophobia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Eye disorders
Vision blurred
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
30.8%
4/13 • Number of events 6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 2
|
66.7%
2/3 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
33.3%
2/6 • Number of events 3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 2
|
38.5%
5/13 • Number of events 7
|
50.0%
3/6 • Number of events 3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 3
|
66.7%
2/3 • Number of events 2
|
100.0%
3/3 • Number of events 6
|
53.8%
7/13 • Number of events 12
|
33.3%
2/6 • Number of events 3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
100.0%
3/3 • Number of events 5
|
38.5%
5/13 • Number of events 6
|
50.0%
3/6 • Number of events 4
|
0.00%
0/3
|
|
General disorders
Catheter site pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
General disorders
Catheter site pruritus
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
General disorders
Chest discomfort
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
General disorders
Chest pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/13
|
33.3%
2/6 • Number of events 2
|
33.3%
1/3 • Number of events 2
|
|
General disorders
Fatigue
|
0.00%
0/3
|
100.0%
3/3 • Number of events 5
|
100.0%
3/3 • Number of events 3
|
30.8%
4/13 • Number of events 5
|
83.3%
5/6 • Number of events 8
|
66.7%
2/3 • Number of events 2
|
|
General disorders
General physical health deterioration
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
General disorders
Generalised oedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Influenza like illness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Malaise
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Infections and infestations
Candidiasis
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
50.0%
3/6 • Number of events 3
|
0.00%
0/3
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
15.4%
2/13 • Number of events 5
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
15.4%
2/13 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
15.4%
2/13 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Investigations
Breath sounds abnormal
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Investigations
Cardiac murmur
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Investigations
Heart rate irregular
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Investigations
Lymph node palpable
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Investigations
Weight decreased
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Investigations
Weight increased
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
30.8%
4/13 • Number of events 5
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
23.1%
3/13 • Number of events 3
|
50.0%
3/6 • Number of events 5
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
23.1%
3/13 • Number of events 3
|
33.3%
2/6 • Number of events 3
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
66.7%
2/3 • Number of events 3
|
7.7%
1/13 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
15.4%
2/13 • Number of events 3
|
0.00%
0/6
|
0.00%
0/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
7.7%
1/13 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Dysgeusia
|
66.7%
2/3 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Nervous system disorders
Syncope
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
|
Nervous system disorders
Tremor
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Psychiatric disorders
Depression
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Penile swelling
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
23.1%
3/13 • Number of events 3
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
50.0%
3/6 • Number of events 3
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Campbell de morgan spots
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Vascular disorders
Flushing
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Vascular disorders
Haematoma
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Vascular disorders
Hot flush
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Vascular disorders
Hypertension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
16.7%
1/6 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3 • Number of events 5
|
0.00%
0/13
|
0.00%
0/6
|
0.00%
0/3
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
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