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Trial record 46 of 201 for:    Ovarian Dysgenesis 1

Dose-Escalation Study of LY573636-sodium and Liposomal Doxorubicin in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT01214668
Recruitment Status : Completed
First Posted : October 5, 2010
Results First Posted : October 16, 2018
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Solid Tumors
Interventions Drug: LY573636-sodium
Drug: Liposomal Doxorubicin
Enrollment 31
Recruitment Details  
Pre-assignment Details The reasons for discontinuation listed in the participant flow are the reasons the participant discontinued treatment and a participant was considered to have "completed" the trial if they experienced progressive disease or an adverse event.
Arm/Group Title LY 300 μg/mL + Dox LY 320 μg/mL + Dox LY 340 μg/mL + Dox LY 360 μg/mL + Dox LY 380 μg/mL + Dox LY Albumin and Day 15 PK Tailored + Dox
Hide Arm/Group Description LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase. LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase. LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase. LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase. LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase. LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour*micrograms per milliliter (h*µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic [PK]) (LY Albumin and Day 15 PK Tailored).
Period Title: Overall Study
Started 4 3 6 6 6 6
Received at Least One Dose of Study Drug 4 3 6 6 6 6
Completed 0 0 0 0 0 0
Not Completed 4 3 6 6 6 6
Reason Not Completed
Adverse Event             0             1             0             2             1             1
Death             0             0             1             0             0             0
Progressive Disease             4             2             5             4             4             5
Withdrawal by Subject             0             0             0             0             1             0
Arm/Group Title LY 300 μg/mL + Dox LY 320 μg/mL + Dox LY 340 μg/mL + Dox LY 360 μg/mL + Dox LY 380 μg/mL + Dox LY Albumin and Day 15 PK Tailored + Dox Total
Hide Arm/Group Description LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase. LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase. LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase. LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase. LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase. LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour*micrograms per milliliter (h*μg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic [PK]) (LY Albumin and Day 15 PK Tailored). Total of all reporting groups
Overall Number of Baseline Participants 4 3 6 6 6 6 31
Hide Baseline Analysis Population Description
All enrolled participants who had at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 6 participants 6 participants 6 participants 6 participants 31 participants
57.39  (13.60) 51.54  (8.55) 64.65  (7.53) 58.57  (2.71) 52.24  (15.08) 57.82  (12.97) 57.54  (10.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 6 participants 6 participants 6 participants 6 participants 31 participants
Female
4
 100.0%
2
  66.7%
6
 100.0%
5
  83.3%
5
  83.3%
6
 100.0%
28
  90.3%
Male
0
   0.0%
1
  33.3%
0
   0.0%
1
  16.7%
1
  16.7%
0
   0.0%
3
   9.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 6 participants 6 participants 6 participants 6 participants 31 participants
Hispanic or Latino
2
  50.0%
1
  33.3%
0
   0.0%
1
  16.7%
2
  33.3%
0
   0.0%
6
  19.4%
Not Hispanic or Latino
2
  50.0%
2
  66.7%
6
 100.0%
5
  83.3%
4
  66.7%
6
 100.0%
25
  80.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 6 participants 6 participants 6 participants 6 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
1
  16.7%
0
   0.0%
2
   6.5%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
3
  75.0%
3
 100.0%
5
  83.3%
6
 100.0%
5
  83.3%
6
 100.0%
28
  90.3%
More than one race
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 6 participants 6 participants 6 participants 6 participants 31 participants
4
 100.0%
3
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
31
 100.0%
1.Primary Outcome
Title Recommended Phase 2 Dose
Hide Description Recommended Phase 2 dose was determined by maximum tolerated dose (MTD), which is corrected for the participant’s predose albumin to identify the albumin-corrected exposure range of LY 573636 when combined with liposomal doxorubicin. MTD is the highest dose with <33% of participants having a dose-limiting toxicity (DLT) in the first 28-day cycle of treatment. DLT is an adverse event (AE) that is likely related to the study drug or combination and fulfills any 1 of the following: Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 hematologic toxicity; Gr 3 nonhematologic toxicity (excluding controllable nausea/vomiting or diarrhea and alopecia); Gr 3 electrolyte toxicity that is not resolved with standard treatments. Those who enter the study with Gr 2 hepatic enzyme abnormalities, DLT for an isolated Gr 3 hepatic enzyme abnormality is determined by investigators; a DLT can be declared if a participant experiences increasing toxicity during treatment.
Time Frame Predose up to 28 days postdose in Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of the study drug.
Arm/Group Title LY 300 μg/mL + Dox LY 320 μg/mL + Dox LY 340 μg/mL + Dox LY 360 μg/mL + Dox LY 380 μg/mL + Dox LY Albumin and Day 15 PK Tailored + Dox
Hide Arm/Group Description:
LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.
LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour*micrograms per milliliter (h*µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic [PK]) (LY Albumin and Day 15 PK Tailored).
Overall Number of Participants Analyzed 4 3 6 6 6 6
Measure Type: Number
Unit of Measure: micrograms per milliliter (μg/mL)
NA [1]  NA [1]  NA [1]  NA [1]  NA [1]  NA [1] 
[1]
MTD was not reached because none of the participants reached the criteria for MTD.
2.Secondary Outcome
Title Number of Participants With Clinically Significant Events
Hide Description Clinically significant events are defined as serious adverse events (SAEs), regardless of causality, during the study including the 30-day follow-up period. A summary of SAEs and other nonserious adverse events is located in the Reported Adverse Event section. Death due to progressive disease was not considered as an SAE.
Time Frame Baseline to study completion up to 18.49 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of the study drug.
Arm/Group Title LY 300 μg/mL + Dox LY 320 μg/mL + Dox LY 340 μg/mL + Dox LY 360 μg/mL + Dox LY 380 μg/mL + Dox LY Albumin and Day 15 PK Tailored + Dox
Hide Arm/Group Description:
LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.
LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour*micrograms per milliliter (h*µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic [PK]) (LY Albumin and Day 15 PK Tailored).
Overall Number of Participants Analyzed 4 3 6 6 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
2 0 5 3 3 3
3.Secondary Outcome
Title Pharmacokinetics: Maximum Concentration (Cmax) of LY573636
Hide Description [Not Specified]
Time Frame Predose, 30 minutes (min), 2 hours (h), 4 h, 166 h, 360 h and 698 h postdose in Cycle 1; Predose, 30 min, 2 h, 4 h, 166 h, 360 h and 698 h postdose in Cycle 2; Predose, 166h, 360h and 698 h postdose in Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received the study drug and had sufficient pharmacokinetic (PK) data to estimate Cmax at the specified time points.
Arm/Group Title LY573636
Hide Arm/Group Description:
LY573636 dose was based on an albumin-corrected exposure (AUCalb) to target a specific exposure range. Intravenous dosing is done on Day 1 of a 28-day cycle. Data are pooled together from all treatment groups.
Overall Number of Participants Analyzed 31
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms per milliliter (µg/mL)
Cycle 1 Number Analyzed 31 participants
335.1
(13.9%)
Cycle 2 Number Analyzed 27 participants
284.5
(15.9%)
Cycle 3 Number Analyzed 21 participants
250.7
(25.2%)
4.Secondary Outcome
Title Number of Participants With Tumor Response
Hide Description Number of participants with tumor response = number of participants with complete response (CR) + number of participants with partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in the sum of longest diameter of target lesions.
Time Frame Baseline to measured progressive disease up to 4.7 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of the study drug.
Arm/Group Title LY 300 μg/mL + Dox LY 320 μg/mL + Dox LY 340 μg/mL + Dox LY 360 μg/mL + Dox LY 380 μg/mL + Dox LY Albumin and Day 15 PK Tailored + Dox
Hide Arm/Group Description:
LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.
LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour*micrograms per milliliter (h*µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic [PK]) (LY Albumin and Day 15 PK Tailored).
Overall Number of Participants Analyzed 4 3 6 6 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
1 0 1 3 0 2
5.Secondary Outcome
Title Pharmacokinetics: Area Under the Curve of LY573636 Above the Albumin Corrected Threshold (AUCalb)
Hide Description LY573636 has been found to be highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) LY573636.
Time Frame Predose, 30 min, 2 h, 4 h, 166 h, 360 h and 698 h postdose in Cycle 1; Predose, 30 min, 2 h, 4 h, 166 h, 360 h and 698 h postdose in Cycle 2; Predose, 166h, 360h and 698 h postdose in Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received the study drug and had sufficient pharmacokinetic (PK) data to calculate AUCalb at the specified time points.
Arm/Group Title LY573636
Hide Arm/Group Description:
LY573636 dose was based on an albumin-corrected exposure (AUCalb) to target a specific exposure range. Intravenous dosing is done on Day 1 of a 28-day cycle. Data are pooled together from all treatment groups.
Overall Number of Participants Analyzed 31
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour*micrograms per milliliter (h*µg/mL)
Cycle 1 Number Analyzed 31 participants
1081.0
(163.9%)
Cycle 2 Number Analyzed 28 participants
413.7
(684.3%)
Cycle 3 Number Analyzed 19 participants
228.4
(323.3%)
6.Other Pre-specified Outcome
Title Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment
Hide Description [Not Specified]
Time Frame From date of randomization until up to 30 days post study treatment discontinuation, assessed up to 4.7 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of the study drug.
Arm/Group Title LY 300 μg/mL + Dox LY 320 μg/mL + Dox LY 340 μg/mL + Dox LY 360 μg/mL + Dox LY 380 μg/mL + Dox LY Albumin and Day 15 PK Tailored + Dox
Hide Arm/Group Description:
LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase.
LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase.
LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour*micrograms per milliliter (h*µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic [PK]) (LY Albumin and Day 15 PK Tailored).
Overall Number of Participants Analyzed 4 3 6 6 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0 0 0 0 0 1
Time Frame [Not Specified]
Adverse Event Reporting Description Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified Outcome Measure for those who died within the 30-day post study treatment follow-up period.
 
Arm/Group Title LY 300 μg/mL + Dox LY 320 μg/mL + Dox LY 340 μg/mL + Dox LY 360 μg/mL + Dox LY 380 μg/mL + Dox LY Albumin and Day 15 PK Tailored + Dox
Hide Arm/Group Description LY573636 targeting a maximum concentration (Cmax) of 300 micrograms per milliliter (μg/mL) (LY 300 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 milligrams per square meter (mg/m²) during the Dose-Escalation Phase. LY573636 targeting a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase. LY573636 targeting a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase. LY573636 targeting a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase. LY573636 targeting a Cmax of 380 μg/mL (LY 380 μg/mL) as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Escalation Phase. LY573636 dosing was given as a 2-hour infusion on Day 1 of a 28-day cycle in combination with liposomal doxorubicin (Dox) at a dose of 40 mg/m² during the Dose-Confirmation Phase. LY573636 dose was based on an albumin-corrected exposure (AUCalb) target range of 75th percentile of 3500 hour*micrograms per milliliter (h*µg/mL) and the Cycle 1, Day 15 LY573636 total drug level (Day 15 pharmacokinetic [PK]) (LY Albumin and Day 15 PK Tailored).
All-Cause Mortality
LY 300 μg/mL + Dox LY 320 μg/mL + Dox LY 340 μg/mL + Dox LY 360 μg/mL + Dox LY 380 μg/mL + Dox LY Albumin and Day 15 PK Tailored + Dox
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY 300 μg/mL + Dox LY 320 μg/mL + Dox LY 340 μg/mL + Dox LY 360 μg/mL + Dox LY 380 μg/mL + Dox LY Albumin and Day 15 PK Tailored + Dox
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/4 (50.00%)      0/3 (0.00%)      5/6 (83.33%)      3/6 (50.00%)      3/6 (50.00%)      3/6 (50.00%)    
Blood and lymphatic system disorders             
Anaemia  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Neutropenia  1  1/4 (25.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Thrombocytopenia  1  1/4 (25.00%)  1 0/3 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Cardiac disorders             
Cardiac arrest  1 [1]  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Ear and labyrinth disorders             
Vertigo  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Gastrointestinal disorders             
Abdominal pain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1
Constipation  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1
Dysphagia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal haemorrhage  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Impaired gastric emptying  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Intestinal obstruction  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Large intestinal obstruction  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Nausea  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Oesophagitis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Small intestinal obstruction  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  3
Stomatitis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Vomiting  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
General disorders             
Mucosal inflammation  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Hepatobiliary disorders             
Dilatation intrahepatic duct acquired  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Immune system disorders             
Drug hypersensitivity  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations             
H1n1 influenza  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Postoperative wound infection  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Sepsis syndrome  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Wound infection  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Investigations             
Blood creatinine increased  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
White blood cell count decreased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Metabolism and nutrition disorders             
Dehydration  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Hypokalaemia  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Muscular weakness  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1
Nervous system disorders             
Subarachnoid haemorrhage  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Vocal cord paralysis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Psychiatric disorders             
Confusional state  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Asthma  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Pneumonia aspiration  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Pneumonitis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders             
Exfoliative rash  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Vascular disorders             
Hypotension  1  1/4 (25.00%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, 15.0
[1]
This event resulted in death.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LY 300 μg/mL + Dox LY 320 μg/mL + Dox LY 340 μg/mL + Dox LY 360 μg/mL + Dox LY 380 μg/mL + Dox LY Albumin and Day 15 PK Tailored + Dox
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      3/3 (100.00%)      6/6 (100.00%)      6/6 (100.00%)      6/6 (100.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders             
Anaemia  1  2/4 (50.00%)  5 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 3/6 (50.00%)  3
Leukopenia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Lymphopenia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Neutropenia  1  0/4 (0.00%)  0 1/3 (33.33%)  2 0/6 (0.00%)  0 2/6 (33.33%)  2 4/6 (66.67%)  5 3/6 (50.00%)  4
Thrombocytopenia  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 3/6 (50.00%)  4 1/6 (16.67%)  1
Cardiac disorders             
Cardiac failure congestive  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Palpitations  1  1/4 (25.00%)  1 1/3 (33.33%)  1 2/6 (33.33%)  2 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Pericardial effusion  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Sinus tachycardia  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Ear and labyrinth disorders             
Deafness  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Ear discomfort  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Ear pain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 3/6 (50.00%)  3 1/6 (16.67%)  1 0/6 (0.00%)  0
Tinnitus  1  0/4 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0
Eye disorders             
Abnormal sensation in eye  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Eye irritation  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Photopsia  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Scleral discolouration  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Vision blurred  1  1/4 (25.00%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 2/6 (33.33%)  2 2/6 (33.33%)  2 1/6 (16.67%)  1
Visual impairment  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal disorders             
Abdominal distension  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Abdominal pain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 3/6 (50.00%)  3 0/6 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2
Abdominal pain upper  1  1/4 (25.00%)  1 2/3 (66.67%)  2 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  3
Anal haemorrhage  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Constipation  1  0/4 (0.00%)  0 2/3 (66.67%)  2 3/6 (50.00%)  3 2/6 (33.33%)  2 2/6 (33.33%)  2 2/6 (33.33%)  2
Diarrhoea  1  2/4 (50.00%)  3 1/3 (33.33%)  1 5/6 (83.33%)  5 2/6 (33.33%)  2 1/6 (16.67%)  2 2/6 (33.33%)  2
Dry mouth  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0
Duodenal ulcer  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Dyspepsia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Dysphagia  1  0/4 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 2/6 (33.33%)  2 2/6 (33.33%)  2 0/6 (0.00%)  0
Faeces hard  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Flatulence  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Gastrointestinal pain  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Gastrooesophageal reflux disease  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Gingival bleeding  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Gingival pain  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Glossodynia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Haematochezia  1  0/4 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Haemorrhoidal haemorrhage  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Intestinal obstruction  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  3
Lip blister  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Lip ulceration  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Mouth ulceration  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Nausea  1  1/4 (25.00%)  2 3/3 (100.00%)  3 3/6 (50.00%)  3 2/6 (33.33%)  2 0/6 (0.00%)  0 3/6 (50.00%)  4
Odynophagia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Oesophagitis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Oral pain  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1
Proctalgia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Rectal haemorrhage  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Rectal ulcer  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Small intestinal obstruction  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Stomatitis  1  2/4 (50.00%)  6 3/3 (100.00%)  3 2/6 (33.33%)  2 4/6 (66.67%)  4 1/6 (16.67%)  1 0/6 (0.00%)  0
Tongue disorder  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Tongue ulceration  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Vomiting  1  2/4 (50.00%)  3 2/3 (66.67%)  2 2/6 (33.33%)  3 0/6 (0.00%)  0 2/6 (33.33%)  3 2/6 (33.33%)  2
General disorders             
Asthenia  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Catheter site pain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Catheter site swelling  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Chest pain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Chills  1  2/4 (50.00%)  3 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Device occlusion  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Early satiety  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Face oedema  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Fatigue  1  2/4 (50.00%)  3 2/3 (66.67%)  2 5/6 (83.33%)  5 2/6 (33.33%)  2 4/6 (66.67%)  5 2/6 (33.33%)  2
Feeling abnormal  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Generalised oedema  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Infusion site pain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Injection site haemorrhage  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Injection site pain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Mucosal inflammation  1  1/4 (25.00%)  2 1/3 (33.33%)  2 2/6 (33.33%)  2 3/6 (50.00%)  4 3/6 (50.00%)  5 3/6 (50.00%)  5
Non-cardiac chest pain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Oedema  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Oedema peripheral  1  1/4 (25.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  3 0/6 (0.00%)  0 1/6 (16.67%)  1
Pain  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Pyrexia  1  4/4 (100.00%)  5 1/3 (33.33%)  1 1/6 (16.67%)  1 2/6 (33.33%)  2 1/6 (16.67%)  1 1/6 (16.67%)  1
Thrombosis in device  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Hepatobiliary disorders             
Gallbladder pain  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations             
Bronchitis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Candidiasis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1
Clostridial infection  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Escherichia infection  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Fungal infection  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0
Gastric infection  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Herpes zoster  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Hordeolum  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Lung infection  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Nasopharyngitis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2 1/6 (16.67%)  1 0/6 (0.00%)  0
Oral candidiasis  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Oral herpes  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Pneumonia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Rash pustular  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Sinusitis  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Urinary tract infection  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2 3/6 (50.00%)  4 4/6 (66.67%)  4
Injury, poisoning and procedural complications             
Contusion  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Facial bones fracture  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2
Fall  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  4
Infusion related reaction  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Laceration  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1
Muscle strain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Nail injury  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Procedural pain  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Investigations             
Blood alkaline phosphatase increased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Blood creatinine  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Blood creatinine increased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Ejection fraction decreased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Haemoglobin decreased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2 1/6 (16.67%)  1 1/6 (16.67%)  1
Neutrophil count decreased  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Weight decreased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 4/6 (66.67%)  4
Weight increased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Metabolism and nutrition disorders             
Decreased appetite  1  1/4 (25.00%)  1 2/3 (66.67%)  2 2/6 (33.33%)  2 3/6 (50.00%)  3 2/6 (33.33%)  2 3/6 (50.00%)  3
Dehydration  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Hyperglycaemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  5 1/6 (16.67%)  1
Hypoalbuminaemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Hypokalaemia  1  1/4 (25.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 2/6 (33.33%)  2 4/6 (66.67%)  7
Hypomagnesaemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2
Hyponatraemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Hypophosphataemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 2/6 (33.33%)  3 1/6 (16.67%)  1 1/6 (16.67%)  1
Arthritis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Back pain  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Joint stiffness  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Joint swelling  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Muscle spasms  1  0/4 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  2 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1
Muscle twitching  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Muscular weakness  1  1/4 (25.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Musculoskeletal discomfort  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal pain  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Myalgia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  2 0/6 (0.00%)  0
Neck pain  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Pain in extremity  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  3 0/6 (0.00%)  0 1/6 (16.67%)  1
Nervous system disorders             
Ataxia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Dizziness  1  1/4 (25.00%)  1 1/3 (33.33%)  1 1/6 (16.67%)  1 3/6 (50.00%)  3 1/6 (16.67%)  1 0/6 (0.00%)  0
Dysgeusia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 2/6 (33.33%)  2 1/6 (16.67%)  1 0/6 (0.00%)  0
Headache  1  2/4 (50.00%)  2 1/3 (33.33%)  1 4/6 (66.67%)  5 4/6 (66.67%)  5 2/6 (33.33%)  2 2/6 (33.33%)  2
Hypoaesthesia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Neuropathy peripheral  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  2 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Paraesthesia  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2 0/6 (0.00%)  0
Sedation  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Tremor  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1
Psychiatric disorders             
Anxiety  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Depression  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Insomnia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0
Libido decreased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Renal and urinary disorders             
Costovertebral angle tenderness  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Dysuria  1  0/4 (0.00%)  0 1/3 (33.33%)  1 2/6 (33.33%)  2 0/6 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2
Haematuria  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0
Hydronephrosis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Hypertonic bladder  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Nocturia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0
Pollakiuria  1  1/4 (25.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Renal failure acute  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Urinary incontinence  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Urinary retention  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Urine abnormality  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Reproductive system and breast disorders             
Genital rash  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Menstruation irregular  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Pelvic pain  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Perineal pain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Pruritus genital  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Vaginal discharge  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Vaginal haemorrhage  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 1/6 (16.67%)  1 0/6 (0.00%)  0
Vaginal odour  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Vulvovaginal pain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Cough  1  2/4 (50.00%)  2 1/3 (33.33%)  1 2/6 (33.33%)  3 2/6 (33.33%)  2 0/6 (0.00%)  0 1/6 (16.67%)  1
Dysphonia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Dyspnoea  1  2/4 (50.00%)  2 0/3 (0.00%)  0 3/6 (50.00%)  3 2/6 (33.33%)  2 2/6 (33.33%)  2 1/6 (16.67%)  1
Epistaxis  1  0/4 (0.00%)  0 1/3 (33.33%)  2 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  2
Nasal congestion  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Nasal dryness  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Oropharyngeal pain  1  0/4 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 2/6 (33.33%)  3
Rhinalgia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2
Sinus disorder  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Sneezing  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Upper-airway cough syndrome  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Wheezing  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders             
Acne  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Alopecia  1  1/4 (25.00%)  1 2/3 (66.67%)  2 1/6 (16.67%)  1 3/6 (50.00%)  3 1/6 (16.67%)  1 4/6 (66.67%)  4
Blister  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Cold sweat  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Dermatitis contact  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Dry skin  1  0/4 (0.00%)  0 2/3 (66.67%)  2 1/6 (16.67%)  1 0/6 (0.00%)  0 2/6 (33.33%)  3 0/6 (0.00%)  0
Exfoliative rash  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2 0/6 (0.00%)  0 1/6 (16.67%)  1
Hyperhidrosis  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Hyperkeratosis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Nail discolouration  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Nail disorder  1  0/4 (0.00%)  0 1/3 (33.33%)  1 2/6 (33.33%)  2 2/6 (33.33%)  2 1/6 (16.67%)  1 0/6 (0.00%)  0
Night sweats  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Onychomadesis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Pain of skin  1  0/4 (0.00%)  0 1/3 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Palmar-plantar erythrodysaesthesia syndrome  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  3 1/6 (16.67%)  1 0/6 (0.00%)  0
Pruritus  1  0/4 (0.00%)  0 1/3 (33.33%)  1 2/6 (33.33%)  2 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Rash  1  0/4 (0.00%)  0 2/3 (66.67%)  5 4/6 (66.67%)  6 3/6 (50.00%)  5 1/6 (16.67%)  1 0/6 (0.00%)  0
Rash generalised  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Rash maculo-papular  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Skin discolouration  1  0/4 (0.00%)  0 2/3 (66.67%)  2 1/6 (16.67%)  2 3/6 (50.00%)  3 1/6 (16.67%)  1 0/6 (0.00%)  0
Skin hyperpigmentation  1  2/4 (50.00%)  3 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0
Skin mass  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Surgical and medical procedures             
Contraceptive diaphragm  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Vascular disorders             
Flushing  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Hot flush  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Hypertension  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Hypotension  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Thrombosis  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01214668     History of Changes
Other Study ID Numbers: 12887
H8K-MC-JZAN ( Other Identifier: Eli Lilly and Company )
First Submitted: October 1, 2010
First Posted: October 5, 2010
Results First Submitted: March 17, 2018
Results First Posted: October 16, 2018
Last Update Posted: January 4, 2019