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A Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial or Epithelial Ovarian Cancer or Carcinosarcoma (P204)

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ClinicalTrials.gov Identifier: NCT03395080
Recruitment Status : Completed
First Posted : January 10, 2018
Results First Posted : June 9, 2023
Last Update Posted : July 12, 2023
Sponsor:
Information provided by (Responsible Party):
Leap Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Endometrial Cancer
Uterine Cancer
Ovarian Cancer
Carcinosarcoma
Interventions Drug: Paclitaxel
Drug: 300mg DKN-01
Drug: 600mg DKN-01
Enrollment 111
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DKN-01 Monotherapy in Recurrent EEC DKN-01+Paclitaxel in Recurrent EEC DKN-01 Monotherapy in Recurrent EOC DKN-01+Paclitaxel in Recurrent EOC DKN-01 300mg Monotherapy in Carcinosarcoma DKN-01 600mg Monotherapy in Carcinosarcoma DKN-01 300mg + Paclitaxel in Carcinosarcoma DKN-01 600 mg + Paclitaxel in Carcinosarcoma
Hide Arm/Group Description 300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion. 300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 administered by IV infusion. 300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion. 300mg DKN-01+paclitaxel in recurrent EOC. DKN-01and paclitaxel administered by IV infusion. 300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion. 600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion. 300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion. 600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Period Title: Overall Study
Started [1] 29 24 14 19 1 8 4 12
Completed [2] 26 21 13 19 1 8 4 10
Not Completed 3 3 1 0 0 0 0 2
[1]
Number Started is the Safety Analysis Set defined as all subjects who received >= 1 administration of assigned study treatment (DKN-01 or paclitaxel).Subjects with carcinosarcoma were initially enrolled in the EEC group to receive monotherapy or DKN-01+paclitaxel, but as part of a subsequent protocol amendment, carcinosarcoma subjects were enrolled & received 600mg DKN-01 or 600mg DKN-01+paclitaxel. Results are reported by disease type and treatment received.
[2]
Number Completed is the Evaluable Analysis Set defined as all subjects who received any amount of DKN-01 and had at least 1 evaluated post-baseline RECIST assessment or were discontinued due to death.
Arm/Group Title DKN-01 Monotherapy in Recurrent EEC DKN-01+Paclitaxel in Recurrent EEC DKN-01 Monotherapy in Recurrent EOC DKN-01+Paclitaxel in Recurrent EOC DKN-01 300mg Monotherapy in Carcinosarcoma DKN-01 600mg Monotherapy in Carcinosarcoma DKN-01 300mg+Paclitaxel in Carcinosarcoma DKN-01 600mg+Paclitaxel in Carcinosarcoma Total
Hide Arm/Group Description 300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion. 300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion. 300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion. 300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion. 300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion. 600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion. 300mg DKN-01 +paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion. 600mg DKN-01 +paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion. Total of all reporting groups
Overall Number of Baseline Participants 29 24 14 19 1 8 4 12 111
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 24 participants 14 participants 19 participants 1 participants 8 participants 4 participants 12 participants 111 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  65.5%
12
  50.0%
5
  35.7%
10
  52.6%
1
 100.0%
2
  25.0%
2
  50.0%
8
  66.7%
59
  53.2%
>=65 years
10
  34.5%
12
  50.0%
9
  64.3%
9
  47.4%
0
   0.0%
6
  75.0%
2
  50.0%
4
  33.3%
52
  46.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 24 participants 14 participants 19 participants 1 participants 8 participants 4 participants 12 participants 111 participants
Female
29
 100.0%
24
 100.0%
14
 100.0%
19
 100.0%
1
 100.0%
8
 100.0%
4
 100.0%
12
 100.0%
111
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 24 participants 14 participants 19 participants 1 participants 8 participants 4 participants 12 participants 111 participants
Hispanic or Latino
4
  13.8%
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
1
  12.5%
0
   0.0%
1
   8.3%
7
   6.3%
Not Hispanic or Latino
25
  86.2%
23
  95.8%
14
 100.0%
18
  94.7%
1
 100.0%
7
  87.5%
4
 100.0%
10
  83.3%
102
  91.9%
Unknown or Not Reported
0
   0.0%
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
2
   1.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 24 participants 14 participants 19 participants 1 participants 8 participants 4 participants 12 participants 111 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
2
   1.8%
Native Hawaiian or Other Pacific Islander
1
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.9%
Black or African American
0
   0.0%
2
   8.3%
2
  14.3%
3
  15.8%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
8
   7.2%
White
27
  93.1%
21
  87.5%
12
  85.7%
16
  84.2%
1
 100.0%
7
  87.5%
4
 100.0%
9
  75.0%
97
  87.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  16.7%
3
   2.7%
1.Primary Outcome
Title Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients
Hide Description Best overall response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to <10mm) or Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)
Time Frame Baseline to study completion (approximately 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Analysis Set (EAS), all subjects who received any amount of DKN-01 and had at least 1 evaluated post-baseline RECIST assessment or were discontinued due to death.
Arm/Group Title DKN-01 Monotherapy in Recurrent EEC DKN-01 + Paclitaxel in Recurrent EEC DKN-01 Monotherapy in Recurrent EOC DKN-01 + Paclitaxel in Recurrent EOC
Hide Arm/Group Description:
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
Overall Number of Participants Analyzed 26 21 13 19
Measure Type: Number
Unit of Measure: participants
ORR 2 0 0 0
Complete Response 1 0 0 0
Partial Response 1 0 0 0
Stable Disease 9 12 6 13
Progressive Disease 15 9 7 6
2.Primary Outcome
Title Number of Subjects With Objective Response Rate (ORR) in Carcinosarcoma (MMMT) Patients
Hide Description Best overall response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to <10mm) or Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)
Time Frame Baseline to study completion (approximately 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Analysis Set, all subjects who received any amount of DKN-01 and had at least 1 evaluated post-baseline RECIST assessment or were discontinued due to death.
Arm/Group Title DKN-01 300mg Monotherapy in Carcinosarcoma DKN-01 600mg Monotherapy in Carcinosarcoma DKN-01 300mg + Paclitaxel in Carcinosarcoma DKN-01 600mg + Paclitaxel in Carcinosarcoma
Hide Arm/Group Description:
300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Overall Number of Participants Analyzed 1 8 4 10
Measure Type: Number
Unit of Measure: participants
Confirmed ORR 0 0 1 1
Complete Response 0 0 0 0
Partial Response 0 0 1 1
Stable Disease 1 1 0 4
Progressive Disease 0 7 3 5
3.Secondary Outcome
Title Number of Subjects With Objective Disease Control Rate (ODCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Hide Description Objective Disease Control Rate (ODCR) was defined as the percentage of subjects with a Best Overall Response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to <10mm), Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters), or Stable Disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as Progressive Disease) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)
Time Frame Baseline to study completion (approximately 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Analysis Set (EAS), all subjects who received any amount of DKN-01 and had at least 1 evaluated post-baseline RECIST assessment or were discontinued due to death.
Arm/Group Title DKN-01 Monotherapy in Recurrent EEC DKN-01 + Paclitaxel in Recurrent EEC DKN-01 Monotherapy in Recurrent EOC DKN-01 + Paclitaxel in Recurrent EOC DKN-01 300mg Monotherapy in Carcinosarcoma DKN-01 600mg Monotherapy in Carcinosarcoma DKN-01 300mg + Paclitaxel in Carcinosarcoma DKN-01 600mg + Paclitaxel in Carcinosarcoma
Hide Arm/Group Description:
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Overall Number of Participants Analyzed 26 21 13 19 1 8 4 10
Measure Type: Count of Participants
Unit of Measure: Participants
11
  42.3%
12
  57.1%
6
  46.2%
13
  68.4%
1
 100.0%
1
  12.5%
1
  25.0%
5
  50.0%
4.Secondary Outcome
Title Overall Survival (OS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Hide Description Overall Survival (OS) is defined as the time from first dose of study drug until date of death due to any cause.
Time Frame Baseline to study completion (maximum 17.6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all subjects who received any amount of DKN-01.
Arm/Group Title DKN-01 Monotherapy in Recurrent EEC DKN-01 + Paclitaxel in Recurrent EEC DKN-01 Monotherapy in Recurrent EOC DKN-01 + Paclitaxel in Recurrent EOC DKN-01 300mg Monotherapy in Carcinosarcoma DKN-01 600mg Monotherapy in Carcinosarcoma DKN-01 300mg + Paclitaxel in Carcinosarcoma DKN-01 600mg + Paclitaxel in Carcinosarcoma
Hide Arm/Group Description:
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Overall Number of Participants Analyzed 29 24 14 19 1 8 4 12
Median (95% Confidence Interval)
Unit of Measure: months
12.2 [1] 
(4.6 to NA)
10.1
(6.5 to 13.6)
10.8
(5.7 to 17.6)
11.9 [1] 
(6.6 to NA)
NA [2] 
(NA to NA)
8.4 [1] 
(1.3 to NA)
7.3 [1] 
(5.3 to NA)
5.7 [1] 
(1.6 to NA)
[1]
NA=Not Estimable. Data are not estimable due to insufficient number of participants with events.
[2]
Data are not estimable due to insufficient number of participants with events.
5.Secondary Outcome
Title Progression-free Survival (PFS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Hide Description Progression-free survival (PFS) is defined as time from first dose of study drug to first documentation of PD (per RECIST 1.1) or death due to any cause.
Time Frame Baseline to study completion (maximum 7.1 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), all subjects who received any amount of DKN-01.
Arm/Group Title DKN-01 Monotherapy in Recurrent EEC DKN-01 + Paclitaxel in Recurrent EEC DKN-01 Monotherapy in Recurrent EOC DKN-01 + Paclitaxel in Recurrent EOC DKN-01 300mg Monotherapy in Carcinosarcoma DKN-01 600mg Monotherapy in Carcinosarcoma DKN-01 300mg + Paclitaxel in Carcinosarcoma DKN-01 600mg + Paclitaxel in Carcinosarcoma
Hide Arm/Group Description:
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
600mg DKN-01 onotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Overall Number of Participants Analyzed 29 24 14 19 1 8 4 10
Median (95% Confidence Interval)
Unit of Measure: months
1.8
(1.7 to 5.5)
3.8
(1.8 to 5.4)
2.1
(1.6 to 3.5)
3.6
(1.8 to 7.1)
11.6 [1] 
(NA to NA)
1.6
(0.5 to 7.9)
2.0
(1.8 to 5.5)
1.9
(0.9 to 4.0)
[1]
NA=not estimable. Data are not estimable due to insufficient number of participants with events.
6.Secondary Outcome
Title Duration of Response (DoR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Hide Description Duration of Response (DoR) includes only patients that have responded with an objective disease response (PR or CR) and is defined as the time from the first tumor assessment that supports the patient's objective disease response to the time of PD or death due to any cause.
Time Frame Baseline to study completion (approximately 11 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed only includes the responders in each group.
Arm/Group Title DKN-01 Monotherapy in Recurrent EEC DKN-01 + Paclitaxel in Recurrent EEC DKN-01 Monotherapy in Recurrent EOC DKN-01 + Paclitaxel in Eecurrent EOC DKN-01 300mg Monotherapy in Carcinosarcoma DKN-01 600mg Monotherapy in Carcinosarcoma DKN-01 300mg + Paclitaxel in Carcinosarcoma DKN-01 600mg + Paclitaxel in Carcinosarcoma
Hide Arm/Group Description:
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
300mg DKN-01 in carcinosarcoma. DKN-01 administered by IV infusion.
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Overall Number of Participants Analyzed 2 0 0 0 0 0 1 1
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
3.7 [2] 
(NA to NA)
NA [3] 
(NA to NA)
[1]
NA = Insufficient number of participants with events. 2 subjects with responses, but only one with an event, Median duration of response could not be estimated as 1 of the 2 subjects response had not had a progression event, therefore the 95% CIs are not estimable. 1 patient remains in response at end of study.
[2]
PR was reported for 1 subject with a progression event therefore no CIs are estimable
[3]
Insufficient number of participants with events. Median duration of response could not be estimated as the 1 subject with PR had not had a progression event.
7.Secondary Outcome
Title Duration of Complete Response (DoCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Hide Description Number of participants analyzed only includes patients with a CR and is otherwise defined and analyzed similar to DoR.
Time Frame Baseline to study completion (approximately 11 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed only includes patients who have responded with an objective disease response (CR).
Arm/Group Title DKN-01 Monotherapy in Recurrent EEC DKN-01 + Paclitaxel in Recurrent EEC DKN-01 Monotherapy in Recurrent EOC DKN-01 + Paclitaxel in Recurrent EOC DKN-01 300mg Monotherapy in Carcinosarcoma DKN-01 600mg Monotherapy in Carcinosarcoma DKN-01 300mg + Paclitaxel in Carcinosarcoma DKN-01 600mg + Paclitaxel in Carcinosarcoma
Hide Arm/Group Description:
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
300mg DKN-01 + paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
300mg DKN-01 + paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
300mg DKN-01 in carcinosarcoma. DKN-01 administered by IV infusion.
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Overall Number of Participants Analyzed 1 0 0 0 0 0 0 0
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
Insufficient number of participants with events.
8.Secondary Outcome
Title Duration of Clinical Benefit (DoCB) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Hide Description Duration of Clinical Benefit (DoCB) includes patients with a Best Overall Response of CR, PR, or SD and is defined as the time from the first tumor assessment of CR, PR or SD to the time of PD or death due to any cause.
Time Frame Baseline to study completion (approximately 13.1 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed only includes patients who had CR, PR, or SD.
Arm/Group Title DKN-01 Monotherapy in Recurrent EEC DKN-01 + Paclitaxel in Recurrent EEC DKN-01 Monotherapy in Recurrent EOC DKN-01 + Paclitaxel in Recurrent EOC DKN-01 300mg Monotherapy in Carcinosarcoma DKN-01 600mg Monotherapy in Carcinosarcoma DKN-01 300mg + Paclitaxel in Carcinsarcoma DKN-01 600mg + Paclitaxel in Carcinosarcoma
Hide Arm/Group Description:
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
300mg DKN-01 in carcinosarcoma. DKN-01 administered by IV infusion.
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Overall Number of Participants Analyzed 11 12 6 13 1 1 1 5
Median (95% Confidence Interval)
Unit of Measure: months
4.7
(1.2 to 9.2)
3.8
(2.0 to 4.2)
1.9
(1.7 to 13.1)
3.9
(1.8 to 5.6)
NA [1] 
(NA to NA)
6.0 [2] 
(NA to NA)
3.7 [2] 
(NA to NA)
2.2 [3] 
(1.9 to NA)
[1]
Subject had a progression event; the Kaplan-Meier estimated median duration of clinical benefit times was not estimable.
[2]
NA = not estimable. Data are not estimable due to insufficient number of participants with events.
[3]
NE = not estimable. Data are not estimable due to insufficient number of participants with events.
9.Other Pre-specified Outcome
Title Number of Subjects With Response to Therapy in Patients With and Without Activating β-catenin Mutations and/or Wnt Signaling Genetic Alterations in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT)
Hide Description [Not Specified]
Time Frame Baseline to study completion (approximately 6 months)
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Dickkopf-1 (DKK1) Concentration in Serum and Plasma Relative to Safety and Efficacy Outcomes in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Hide Description [Not Specified]
Time Frame Baseline to study completion (approximately 6 months)
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Number of Subjects With Adverse Drug Reactions and Toxicities as Evaluated by NCI CTCAE v5.0 of DKN-01 600 mg +/- Paclitaxel in Patients With Recurrent Carcinosarcoma (MMMT) in Carcinosarcoma (MMMT) Patients
Hide Description [Not Specified]
Time Frame Baseline to study completion (approximately 6 months)
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Hide Description [Not Specified]
Time Frame Baseline to study completion (approximately 6 months)
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Maximum Plasma Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Baseline to study completion (approximately 6 months)
Outcome Measure Data Not Reported
14.Other Pre-specified Outcome
Title Time Taken to Reach the Maximum Plasma Concentration (Tmax)
Hide Description [Not Specified]
Time Frame Baseline to study completion (approximately 6 months)
Outcome Measure Data Not Reported
15.Other Pre-specified Outcome
Title Area Under the Curve (AUC)
Hide Description [Not Specified]
Time Frame Baseline to study completion (approximately 6 months)
Outcome Measure Data Not Reported
16.Other Pre-specified Outcome
Title Number of Subjects With Adverse Drug Reactions and Toxicities as Evaluated by NCI CTCAE v4.03 as DKN-01 as Monotherapy or in Combination With Paclitaxel in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT)
Hide Description [Not Specified]
Time Frame Baseline to study completion (approximately 6 months)
Outcome Measure Data Not Reported
17.Other Pre-specified Outcome
Title Number of Subjects With Adverse Drug Reactions and Toxicities to Study Treatment Regimen in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT) as Evaluated by NCI CTCAE v5.0
Hide Description [Not Specified]
Time Frame Baseline to study completion (approximately 6 months)
Outcome Measure Data Not Reported
18.Other Pre-specified Outcome
Title Concentration of DKN-01 Antibodies in Human Serum in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT)
Hide Description [Not Specified]
Time Frame Baseline to study completion (approximately 6 months)
Outcome Measure Data Not Reported
Time Frame The Safety Analysis Set is all subjects who received greater than or equal to 1 administration of assigned study treatment (DKN-01 or paclitaxel). Subjects were followed for treatment emergent adverse events (AE), defined as any AE with an onset or worsening of a pre-existing condition on or after the first dose of the study drug through 30 days following the last dose of study drug, up to approximately 2 years.
Adverse Event Reporting Description Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment and within 30 days after the last study treatment dose.
 
Arm/Group Title DKN-01 Monotherapy in Recurrent EEC DKN-01+Paclitaxel in Recurrent EEC DKN-01 Monotherapy in Recurrent EOC DKN-01+Paclitaxel in Recurrent EOC 300mg DKN-01 Monotherapy in Carcinosarcoma 600mg DKN-01 Monotherapy in Carcinosarcoma 300mg DKN-01+Paclitaxel in Carcinosarcoma 600mg DKN-01+Paclitaxel in Carcinosarcoma
Hide Arm/Group Description 300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion. 300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 administered by IV infusion. 300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion. 300mg DKN-01+paclitaxel in recurrent EOC. DKN-01and paclitaxel administered by IV infusion. 300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion. 600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion. 300mg DKN-01+paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion. 600mg DKN-01+paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
All-Cause Mortality
DKN-01 Monotherapy in Recurrent EEC DKN-01+Paclitaxel in Recurrent EEC DKN-01 Monotherapy in Recurrent EOC DKN-01+Paclitaxel in Recurrent EOC 300mg DKN-01 Monotherapy in Carcinosarcoma 600mg DKN-01 Monotherapy in Carcinosarcoma 300mg DKN-01+Paclitaxel in Carcinosarcoma 600mg DKN-01+Paclitaxel in Carcinosarcoma
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/29 (48.28%)      16/24 (66.67%)      11/14 (78.57%)      12/19 (63.16%)      0/1 (0.00%)      4/8 (50.00%)      2/4 (50.00%)      8/12 (66.67%)    
Hide Serious Adverse Events
DKN-01 Monotherapy in Recurrent EEC DKN-01+Paclitaxel in Recurrent EEC DKN-01 Monotherapy in Recurrent EOC DKN-01+Paclitaxel in Recurrent EOC 300mg DKN-01 Monotherapy in Carcinosarcoma 600mg DKN-01 Monotherapy in Carcinosarcoma 300mg DKN-01+Paclitaxel in Carcinosarcoma 600mg DKN-01+Paclitaxel in Carcinosarcoma
Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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   8/29 (27.59%)      13/24 (54.17%)      1/14 (7.14%)      6/19 (31.58%)      1/1 (100.00%)      2/8 (25.00%)      0/4 (0.00%)      6/12 (50.00%)    
Blood and lymphatic system disorders                 
Anaemia † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Cardiac disorders                 
Sinus node dysfunction † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Atrial fibrillation † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/12 (0.00%) 
Gastrointestinal disorders                 
Nausea † 1  2/29 (6.90%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Abdominal pain † 1  1/29 (3.45%)  1/24 (4.17%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Gastrointestinal haemorrhage † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Gastrointestinal perforation † 1  0/29 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Large intestinal obstruction † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Vomiting † 1  1/29 (3.45%)  1/24 (4.17%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Ascites † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  1/12 (8.33%) 
Small intestinal obstruction † 1  0/29 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Colitis † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
General disorders                 
Oedema peripheral † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/12 (0.00%) 
Non-cardiac chest pain † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Pyrexia † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Hepatobiliary disorders                 
Cholecystitis acute † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Infections and infestations                 
Urinary tract infection † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Abdominal abscess † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Sepsis † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Vulval abscess † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Catheter site cellulitis † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Upper respiratory tract infection † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Injury, poisoning and procedural complications                 
Fall † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Post procedural bile leak † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Metabolism and nutrition disorders                 
Hypercalcaemia † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Hyperkalaemia † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Hypokalaemia † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Hyponatremia † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders                 
Pain in extremity † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Nervous system disorders                 
Paraesthesia † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Syncope † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Psychiatric disorders                 
Mania † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Renal and urinary disorders                 
Acute kidney injury † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Urinary tract obstruction † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/12 (0.00%) 
Haematuria † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Hydronephrosis † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Pulmonary embolism † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  1/1 (100.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Dyspnoea † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/12 (0.00%) 
Pleural effusion † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Vascular disorders                 
Deep vein thrombosis † 1  0/29 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Embolism † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
1
Term from vocabulary, MedDRA (18.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DKN-01 Monotherapy in Recurrent EEC DKN-01+Paclitaxel in Recurrent EEC DKN-01 Monotherapy in Recurrent EOC DKN-01+Paclitaxel in Recurrent EOC 300mg DKN-01 Monotherapy in Carcinosarcoma 600mg DKN-01 Monotherapy in Carcinosarcoma 300mg DKN-01+Paclitaxel in Carcinosarcoma 600mg DKN-01+Paclitaxel in Carcinosarcoma
Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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   29/29 (100.00%)      24/24 (100.00%)      13/14 (92.86%)      19/19 (100.00%)      1/1 (100.00%)      8/8 (100.00%)      4/4 (100.00%)      12/12 (100.00%)    
Blood and lymphatic system disorders                 
Anaemia † 1  7/29 (24.14%)  13/24 (54.17%)  2/14 (14.29%)  3/19 (15.79%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  4/12 (33.33%) 
Neutropenia † 1  1/29 (3.45%)  5/24 (20.83%)  1/14 (7.14%)  5/19 (26.32%)  0/1 (0.00%)  0/8 (0.00%)  1/4 (25.00%)  2/12 (16.67%) 
Thrombocytopenia † 1  1/29 (3.45%)  1/24 (4.17%)  1/14 (7.14%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Abdominal lymphadenopathy † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Iron deficiency anaemia † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Leukopenia † 1  1/29 (3.45%)  4/24 (16.67%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  2/12 (16.67%) 
Lymphadenopathy † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Lymphopenia † 1  1/29 (3.45%)  5/24 (20.83%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Cardiac disorders                 
Tachycardia † 1  2/29 (6.90%)  2/24 (8.33%)  0/14 (0.00%)  2/19 (10.53%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Bradycardia † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Sinus arrest † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Sinus node dysfunction † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Atrial fibrillation † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/12 (0.00%) 
Palpitations † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/12 (0.00%) 
Sinus tachycardia † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Ear and labyrinth disorders                 
Vertigo † 1  2/29 (6.90%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Deafness † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Ear pain † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/12 (0.00%) 
Eye disorders                 
Vision blurred † 1  1/29 (3.45%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Dry eye † 1  1/29 (3.45%)  1/24 (4.17%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Cataract † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Conjunctival haemorrhage † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Retinal tear † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Vitreous haemorrhage † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Gastrointestinal disorders                 
Nausea † 1  14/29 (48.28%)  10/24 (41.67%)  8/14 (57.14%)  8/19 (42.11%)  0/1 (0.00%)  1/8 (12.50%)  2/4 (50.00%)  4/12 (33.33%) 
Constipation † 1  5/29 (17.24%)  6/24 (25.00%)  4/14 (28.57%)  2/19 (10.53%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  3/12 (25.00%) 
Vomiting † 1  7/29 (24.14%)  6/24 (25.00%)  2/14 (14.29%)  5/19 (26.32%)  0/1 (0.00%)  1/8 (12.50%)  1/4 (25.00%)  4/12 (33.33%) 
Abdominal pain † 1  5/29 (17.24%)  5/24 (20.83%)  3/14 (21.43%)  6/19 (31.58%)  0/1 (0.00%)  2/8 (25.00%)  0/4 (0.00%)  4/12 (33.33%) 
Abdominal distension † 1  4/29 (13.79%)  6/24 (25.00%)  3/14 (21.43%)  2/19 (10.53%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Diarrhoea † 1  4/29 (13.79%)  7/24 (29.17%)  3/14 (21.43%)  10/19 (52.63%)  0/1 (0.00%)  1/8 (12.50%)  1/4 (25.00%)  1/12 (8.33%) 
Abdominal pain upper † 1  1/29 (3.45%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  2/12 (16.67%) 
Small intestinal obstruction † 1  2/29 (6.90%)  2/24 (8.33%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Abdominal discomfort † 1  0/29 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Abdominal hernia † 1  0/29 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Abdominal tenderness † 1  0/29 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Abdominal wall cyst † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Dry mouth † 1  1/29 (3.45%)  2/24 (8.33%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Dyspepsia † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  2/19 (10.53%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  3/12 (25.00%) 
Dysphagia † 1  0/29 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Faecal incontinence † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Faeces discoloured † 1  0/29 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Flatulence † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  2/19 (10.53%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Gastrointestinal haemorrhage † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Gastrointestinal perforation † 1  0/29 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Gastrooesophageal reflux disease † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  1/8 (12.50%)  1/4 (25.00%)  3/12 (25.00%) 
Haemorrhoids † 1  0/29 (0.00%)  3/24 (12.50%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Intestinal obstruction † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Large intestinal obstruction † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Oral pain † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Proctalgia † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Stomatitis † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  3/19 (15.79%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Tooth impacted † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Ascites † 1  0/29 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  4/19 (21.05%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  1/12 (8.33%) 
Abdominal pain lower † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Anal haemorrhage † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Anorectal discomfort † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Colitis † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Epigastric discomfort † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Toothache † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Eructation † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Gastrointestinal pain † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Hiatus hernia † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
General disorders                 
Fatigue † 1  13/29 (44.83%)  11/24 (45.83%)  9/14 (64.29%)  7/19 (36.84%)  0/1 (0.00%)  2/8 (25.00%)  0/4 (0.00%)  7/12 (58.33%) 
Oedema peripheral † 1  4/29 (13.79%)  8/24 (33.33%)  0/14 (0.00%)  4/19 (21.05%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  2/12 (16.67%) 
Chills † 1  2/29 (6.90%)  3/24 (12.50%)  0/14 (0.00%)  2/19 (10.53%)  1/1 (100.00%)  1/8 (12.50%)  1/4 (25.00%)  0/12 (0.00%) 
Pyrexia † 1  2/29 (6.90%)  2/24 (8.33%)  0/14 (0.00%)  3/19 (15.79%)  1/1 (100.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Asthenia † 1  1/29 (3.45%)  2/24 (8.33%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Gait disturbance † 1  0/29 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Influenza like illness † 1  1/29 (3.45%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Pain † 1  0/29 (0.00%)  1/24 (4.17%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Generalised oedema † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/12 (0.00%) 
Non-cardiac chest pain † 1  0/29 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Local swelling † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Localised oedema † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Thirst † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Catheter site hypersensitivity † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Medical device pain † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Medical device site pain † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Peripheral swelling † 1  0/29 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Hepatobiliary disorders                 
Hyperbilirubinaemia † 1  3/29 (10.34%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/12 (0.00%) 
Hepatic failure † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Cholecystitis acute † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Immune system disorders                 
Seasonal allergy † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/0  0/0  0 0/12 (0.00%)  0
Infections and infestations                 
Urinary tract infection † 1  4/29 (13.79%)  6/24 (25.00%)  0/14 (0.00%)  6/19 (31.58%)  0/1 (0.00%)  3/8 (37.50%)  1/4 (25.00%)  1/12 (8.33%) 
Sinusitis † 1  3/29 (10.34%)  2/24 (8.33%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/12 (0.00%) 
Bronchitis † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  1/1 (100.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Upper respiratory tract infection † 1  2/29 (6.90%)  1/24 (4.17%)  0/14 (0.00%)  3/19 (15.79%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  2/12 (16.67%) 
Fungal infection † 1  0/29 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Hordeolum † 1  0/29 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Nail infection † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Nasopharyngitis † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Oral candidiasis † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/12 (0.00%) 
Pneumonia † 1  1/29 (3.45%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Tooth infection † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Viral upper respiratory tract infection † 1  0/29 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Cellulitis † 1  0/29 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Sepsis † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Abdominal abscess † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Candida infection † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Cystitis † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Localised infection † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Lung infection † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Otitis media † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Urinary tract infection eterococcal † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Vulval abscess † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Asymptomatic bacteriuria † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Catheter site cellulitis † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Vulvovaginal mycotic infection † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Injury, poisoning and procedural complications                 
Procedural pain † 1  2/29 (6.90%)  2/24 (8.33%)  0/14 (0.00%)  0/19 (0.00%)  1/1 (100.00%)  0/8 (0.00%)  1/4 (25.00%)  1/12 (8.33%) 
Excoriation † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Fall † 1  0/29 (0.00%)  2/24 (8.33%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Laceration † 1  0/29 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Meniscus injury † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Nail injury † 1  0/29 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Stoma site pain † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Vascular access complication † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Animal scratch † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/12 (0.00%) 
Infusion related reaction † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  1/8 (12.50%)  1/4 (25.00%)  1/12 (8.33%) 
Contusion † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  1/4 (25.00%)  0/12 (0.00%) 
Compression fracture † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Fracture † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Gastrointestinal stoma complication † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Head injury † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Post procedural bile leak † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Procedural headache † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Investigations                 
Aspartate aminotransferase increased † 1  5/29 (17.24%)  0/24 (0.00%)  1/14 (7.14%)  1/19 (5.26%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  2/12 (16.67%) 
Alanine aminotransferase increased † 1  4/29 (13.79%)  0/24 (0.00%)  1/14 (7.14%)  1/19 (5.26%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  2/12 (16.67%) 
Blood alkaline phosphatase increased † 1  3/29 (10.34%)  2/24 (8.33%)  2/14 (14.29%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  1/12 (8.33%) 
Blood cholesterol increased † 1  2/29 (6.90%)  1/24 (4.17%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  2/12 (16.67%) 
Blood creatinine increased † 1  2/29 (6.90%)  1/24 (4.17%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  2/12 (16.67%) 
Blood lactate dehydrogenase increased † 1  0/29 (0.00%)  1/24 (4.17%)  2/14 (14.29%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Weight decreased † 1  2/29 (6.90%)  2/24 (8.33%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  2/12 (16.67%) 
Amylase increased † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Blood bilirubin increased † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Blood creatine phosphokinase increased † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  2/12 (16.67%) 
Gamma-glutamyltransferase increased † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
International normalised ratio increased † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Lipase increased † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Vitamin D decreased † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Protein total decreased † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/12 (0.00%) 
Weight increased † 1  0/29 (0.00%)  3/24 (12.50%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/12 (0.00%) 
Activate partial thromboplastin time prolonged † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Blood creatine increased † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
White blood cell count decreased † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Metabolism and nutrition disorders                 
Decreased appetite † 1  5/29 (17.24%)  5/24 (20.83%)  2/14 (14.29%)  2/19 (10.53%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  4/12 (33.33%) 
Hyperglycaemia † 1  3/29 (10.34%)  5/24 (20.83%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Hypokalaemia † 1  3/29 (10.34%)  4/24 (16.67%)  1/14 (7.14%)  3/19 (15.79%)  0/1 (0.00%)  1/8 (12.50%)  1/4 (25.00%)  1/12 (8.33%) 
Hypomagnesaemia † 1  3/29 (10.34%)  4/24 (16.67%)  1/14 (7.14%)  3/19 (15.79%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  2/12 (16.67%) 
Hypophosphataemia † 1  2/29 (6.90%)  2/24 (8.33%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Hyperkalaemia † 1  1/29 (3.45%)  2/24 (8.33%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  1/4 (25.00%)  1/12 (8.33%) 
Hyperuricaemia † 1  1/29 (3.45%)  1/24 (4.17%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Hypoalbuminaemia † 1  2/29 (6.90%)  3/24 (12.50%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Hyponatraemia † 1  1/29 (3.45%)  6/24 (25.00%)  1/14 (7.14%)  2/19 (10.53%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  4/12 (33.33%) 
Hypercalcaemia † 1  1/29 (3.45%)  2/24 (8.33%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Dehydration † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/12 (0.00%) 
Appetite disorder † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Hypocalcaemia † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Hypochloraemia † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Iron deficiency † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Type 1 diabetes mellitus † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Hypermagnesaemia † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Hypoglycaemia † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders                 
Arthralgia † 1  6/29 (20.69%)  4/24 (16.67%)  2/14 (14.29%)  3/19 (15.79%)  1/1 (100.00%)  1/8 (12.50%)  0/4 (0.00%)  1/12 (8.33%) 
Back pain † 1  3/29 (10.34%)  7/24 (29.17%)  2/14 (14.29%)  0/19 (0.00%)  1/1 (100.00%)  2/8 (25.00%)  0/4 (0.00%)  2/12 (16.67%) 
Muscular weakness † 1  3/29 (10.34%)  0/24 (0.00%)  2/14 (14.29%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  1/4 (25.00%)  0/12 (0.00%) 
Muscle spasms † 1  2/29 (6.90%)  2/24 (8.33%)  1/14 (7.14%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Myalgia † 1  3/29 (10.34%)  5/24 (20.83%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  3/12 (25.00%) 
Pain in extremity † 1  1/29 (3.45%)  3/24 (12.50%)  2/14 (14.29%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  2/12 (16.67%) 
Bone pain † 1  1/29 (3.45%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Arthritis † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Bursitis † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Flank pain † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  2/8 (25.00%)  1/4 (25.00%)  0/12 (0.00%) 
Foot deformity † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Groin pain † 1  1/29 (3.45%)  2/24 (8.33%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Musculoskeletal chest pain † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Spinal column stenosis † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Neck pain † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  1/12 (8.33%) 
Musculoskeletal pain † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Joint swelling † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Osteopenia † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Pain in jaw † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Metastases to central nervous system † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/0  0/12 (0.00%) 
Oncologic complication † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/0  0/12 (0.00%) 
Basal cell carcinoma † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Nervous system disorders                 
Headache † 1  4/29 (13.79%)  4/24 (16.67%)  3/14 (21.43%)  4/19 (21.05%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  2/12 (16.67%) 
Dizziness † 1  5/29 (17.24%)  5/24 (20.83%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  1/12 (8.33%) 
Dysgeusia † 1  3/29 (10.34%)  6/24 (25.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  1/12 (8.33%) 
Neuropathy peripheral † 1  2/29 (6.90%)  4/24 (16.67%)  1/14 (7.14%)  3/19 (15.79%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  3/12 (25.00%) 
Amnesia † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Lethargy † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Paraesthesia † 1  0/29 (0.00%)  2/24 (8.33%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Parosmia † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Tension headache † 1  0/29 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Tremor † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Peripheral sensory neuropathy † 1  0/29 (0.00%)  3/24 (12.50%)  0/14 (0.00%)  3/19 (15.79%)  0/1 (0.00%)  1/8 (12.50%)  1/4 (25.00%)  1/12 (8.33%) 
Aphasia † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Memory impairment † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Restless leg syndrome † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Sedation † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Sinus headache † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Syncope † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Somnolence † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Psychiatric disorders                 
Anxiety † 1  1/29 (3.45%)  2/24 (8.33%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Insomnia † 1  2/29 (6.90%)  2/24 (8.33%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  1/4 (25.00%)  3/12 (25.00%) 
Confusional state † 1  1/29 (3.45%)  2/24 (8.33%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Depression † 1  1/29 (3.45%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  2/12 (16.67%) 
Irritability † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Mania † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Renal and urinary disorders                 
Dysuria † 1  3/29 (10.34%)  3/24 (12.50%)  1/14 (7.14%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Haematuria † 1  3/29 (10.34%)  3/24 (12.50%)  1/14 (7.14%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Pollakiuria † 1  3/29 (10.34%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  1/1 (100.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Acute kidney injury † 1  2/29 (6.90%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Proteinuria † 1  2/29 (6.90%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Urinary hesitation † 1  1/29 (3.45%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Urinary tract obstruction † 1  2/29 (6.90%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/12 (0.00%) 
Chromaturia † 1  0/29 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Hypertonic bladder † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Micturition urgency † 1  1/29 (3.45%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Nephrolithiasis † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Urinary incontinence † 1  0/29 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Urinary retention † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Urine odour abnormal † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Bladder pain † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Hydronephrosis † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Renal failure † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Reproductive system and breast disorders                 
Vaginal haemorrhage † 1  3/29 (10.34%)  2/24 (8.33%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/12 (0.00%) 
Pelvic pain † 1  2/29 (6.90%)  3/24 (12.50%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Vaginal discharge † 1  0/29 (0.00%)  1/24 (4.17%)  1/14 (7.14%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Vulvovaginal pain † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Breast tenderness † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Oedema genital † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Dyspnoea † 1  4/29 (13.79%)  5/24 (20.83%)  3/14 (21.43%)  3/19 (15.79%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Cough † 1  2/29 (6.90%)  7/24 (29.17%)  1/14 (7.14%)  2/19 (10.53%)  0/1 (0.00%)  0/8 (0.00%)  1/4 (25.00%)  1/12 (8.33%) 
Wheezing † 1  3/29 (10.34%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Oropharyngeal pain † 1  2/29 (6.90%)  1/24 (4.17%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Pleural effusion † 1  1/29 (3.45%)  1/24 (4.17%)  1/14 (7.14%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Dysphonia † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Pulmonary embolism † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  1/1 (100.00%)  1/8 (12.50%)  0/4 (0.00%)  1/12 (8.33%) 
Sneezing † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Upper-airway cough syndrome † 1  1/29 (3.45%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Productive cough † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Sleep apnoea syndrome † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Nasal congestion † 1  0/29 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Dyspnoea exertional † 1  0/29 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Epistaxis † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Hypoxia † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Pleurisy † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Pneumonia aspiration † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Pulmonary congestion † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Sinus congestion † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Rhinitis allergic † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Skin and subcutaneous tissue disorders                 
Dry skin † 1  2/29 (6.90%)  2/24 (8.33%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Night sweats † 1  1/29 (3.45%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Pruritus † 1  2/29 (6.90%)  2/24 (8.33%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  1/12 (8.33%) 
Rash † 1  1/29 (3.45%)  2/24 (8.33%)  1/14 (7.14%)  2/19 (10.53%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Alopecia † 1  0/29 (0.00%)  8/24 (33.33%)  0/14 (0.00%)  8/19 (42.11%)  1/1 (100.00%)  0/8 (0.00%)  1/4 (25.00%)  0/12 (0.00%) 
Dermatitis acneiform † 1  0/29 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Dermatitis bullous † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Eczema † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Hyperhidrosis † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Ingrowing nail † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Nail ridging † 1  1/29 (3.45%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Pain of skin † 1  0/29 (0.00%)  1/24 (4.17%)  1/14 (7.14%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Skin ulcer † 1  1/29 (3.45%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Rash maculo-papular † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  1/12 (8.33%) 
Dermatitus allergic † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  1/4 (25.00%)  0/12 (0.00%) 
Erythema † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Nail discoloration † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Nail disorder † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Onychoclasis † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Onycholysis † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Onychomadesis † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Rash macular † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Cold sweat † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Skin irritation † 1  0/29 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Surgical and medical procedures                 
Sinus operation † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Vascular disorders                 
Hypertension † 1  3/29 (10.34%)  3/24 (12.50%)  1/14 (7.14%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Deep vein thrombosis † 1  0/29 (0.00%)  3/24 (12.50%)  0/14 (0.00%)  0/19 (0.00%)  1/1 (100.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Flushing † 1  0/29 (0.00%)  3/24 (12.50%)  1/14 (7.14%)  2/19 (10.53%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Hot flush † 1  1/29 (3.45%)  1/24 (4.17%)  0/14 (0.00%)  2/19 (10.53%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Hypotension † 1  1/29 (3.45%)  3/24 (12.50%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/12 (8.33%) 
Haematoma † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/12 (0.00%) 
Embolism † 1  0/29 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Lymphoedema † 1  0/29 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
Thrombophlebitis superficial † 1  0/29 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/12 (0.00%) 
1
Term from vocabulary, MedDRA (18.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Cynthia Sirard, MD, Chief Medical Officer
Organization: Leap Therapeutics, Inc.
Phone: +1-617-714-0360
EMail: csirard@leaptx.com
Layout table for additonal information
Responsible Party: Leap Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03395080    
Other Study ID Numbers: DEK-DKK1-P204
First Submitted: January 2, 2018
First Posted: January 10, 2018
Results First Submitted: January 17, 2023
Results First Posted: June 9, 2023
Last Update Posted: July 12, 2023