Trial Outcomes & Findings for 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 (NCT NCT03395080)

NCT ID: NCT03395080

Last Updated: 2025-08-01

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

111 participants

Primary outcome timeframe

Baseline to study completion (approximately 6 months)

Results posted on

2025-08-01

Participant Flow

Participant milestones

Participant milestones
Measure
DKN-01 Monotherapy in Recurrent EEC
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
DKN-01+Paclitaxel in Recurrent EEC
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 administered by IV infusion.
DKN-01 Monotherapy in Recurrent EOC
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
DKN-01+Paclitaxel in Recurrent EOC
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01and paclitaxel administered by IV infusion.
DKN-01 300mg Monotherapy in Carcinosarcoma
300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 600mg Monotherapy in Carcinosarcoma
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 300mg + Paclitaxel in Carcinosarcoma
300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 600 mg + Paclitaxel in Carcinosarcoma
600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Overall Study
STARTED
29
24
14
19
1
8
4
12
Overall Study
COMPLETED
26
21
13
19
1
8
4
10
Overall Study
NOT COMPLETED
3
3
1
0
0
0
0
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
DKN-01 Monotherapy in Recurrent EEC
n=29 Participants
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
DKN-01+Paclitaxel in Recurrent EEC
n=24 Participants
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 Monotherapy in Recurrent EOC
n=14 Participants
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
DKN-01+Paclitaxel in Recurrent EOC
n=19 Participants
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 300mg Monotherapy in Carcinosarcoma
n=1 Participants
300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 600mg Monotherapy in Carcinosarcoma
n=8 Participants
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 300mg+Paclitaxel in Carcinosarcoma
n=4 Participants
300mg DKN-01 +paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 600mg+Paclitaxel in Carcinosarcoma
n=12 Participants
600mg DKN-01 +paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Total
n=111 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
Age, Categorical
Between 18 and 65 years
19 Participants
n=5 Participants
12 Participants
n=7 Participants
5 Participants
n=5 Participants
10 Participants
n=4 Participants
1 Participants
n=21 Participants
2 Participants
n=8 Participants
2 Participants
n=8 Participants
8 Participants
n=24 Participants
59 Participants
n=42 Participants
Age, Categorical
>=65 years
10 Participants
n=5 Participants
12 Participants
n=7 Participants
9 Participants
n=5 Participants
9 Participants
n=4 Participants
0 Participants
n=21 Participants
6 Participants
n=8 Participants
2 Participants
n=8 Participants
4 Participants
n=24 Participants
52 Participants
n=42 Participants
Sex: Female, Male
Female
29 Participants
n=5 Participants
24 Participants
n=7 Participants
14 Participants
n=5 Participants
19 Participants
n=4 Participants
1 Participants
n=21 Participants
8 Participants
n=8 Participants
4 Participants
n=8 Participants
12 Participants
n=24 Participants
111 Participants
n=42 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
0 Participants
n=8 Participants
1 Participants
n=24 Participants
7 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants
n=5 Participants
23 Participants
n=7 Participants
14 Participants
n=5 Participants
18 Participants
n=4 Participants
1 Participants
n=21 Participants
7 Participants
n=8 Participants
4 Participants
n=8 Participants
10 Participants
n=24 Participants
102 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
1 Participants
n=24 Participants
2 Participants
n=42 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
1 Participants
n=24 Participants
2 Participants
n=42 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
1 Participants
n=42 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
3 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
8 Participants
n=42 Participants
Race (NIH/OMB)
White
27 Participants
n=5 Participants
21 Participants
n=7 Participants
12 Participants
n=5 Participants
16 Participants
n=4 Participants
1 Participants
n=21 Participants
7 Participants
n=8 Participants
4 Participants
n=8 Participants
9 Participants
n=24 Participants
97 Participants
n=42 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
2 Participants
n=24 Participants
3 Participants
n=42 Participants

PRIMARY outcome

Timeframe: Baseline to study completion (approximately 6 months)

Population: 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.

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)

Outcome measures

Outcome measures
Measure
DKN-01 Monotherapy in Recurrent EEC
n=26 Participants
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
DKN-01 + Paclitaxel in Recurrent EEC
n=21 Participants
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 Monotherapy in Recurrent EOC
n=13 Participants
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
DKN-01 + Paclitaxel in Recurrent EOC
n=19 Participants
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 300mg Monotherapy in Carcinosarcoma
300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 600mg Monotherapy in Carcinosarcoma
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 300mg + Paclitaxel in Carcinosarcoma
300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 600mg + Paclitaxel in Carcinosarcoma
600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients
Progressive Disease
15 participants
9 participants
7 participants
6 participants
Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients
ORR
2 participants
0 participants
0 participants
0 participants
Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients
Complete Response
1 participants
0 participants
0 participants
0 participants
Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients
Partial Response
1 participants
0 participants
0 participants
0 participants
Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients
Stable Disease
9 participants
12 participants
6 participants
13 participants

PRIMARY outcome

Timeframe: Baseline to study completion (approximately 6 months)

Population: 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.

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)

Outcome measures

Outcome measures
Measure
DKN-01 Monotherapy in Recurrent EEC
n=1 Participants
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
DKN-01 + Paclitaxel in Recurrent EEC
n=8 Participants
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 Monotherapy in Recurrent EOC
n=4 Participants
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
DKN-01 + Paclitaxel in Recurrent EOC
n=10 Participants
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 300mg Monotherapy in Carcinosarcoma
300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 600mg Monotherapy in Carcinosarcoma
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 300mg + Paclitaxel in Carcinosarcoma
300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 600mg + Paclitaxel in Carcinosarcoma
600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Number of Subjects With Objective Response Rate (ORR) in Carcinosarcoma (MMMT) Patients
Confirmed ORR
0 participants
0 participants
1 participants
1 participants
Number of Subjects With Objective Response Rate (ORR) in Carcinosarcoma (MMMT) Patients
Complete Response
0 participants
0 participants
0 participants
0 participants
Number of Subjects With Objective Response Rate (ORR) in Carcinosarcoma (MMMT) Patients
Partial Response
0 participants
0 participants
1 participants
1 participants
Number of Subjects With Objective Response Rate (ORR) in Carcinosarcoma (MMMT) Patients
Stable Disease
1 participants
1 participants
0 participants
4 participants
Number of Subjects With Objective Response Rate (ORR) in Carcinosarcoma (MMMT) Patients
Progressive Disease
0 participants
7 participants
3 participants
5 participants

SECONDARY outcome

Timeframe: Baseline to study completion (approximately 6 months)

Population: 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.

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)

Outcome measures

Outcome measures
Measure
DKN-01 Monotherapy in Recurrent EEC
n=26 Participants
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
DKN-01 + Paclitaxel in Recurrent EEC
n=21 Participants
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 Monotherapy in Recurrent EOC
n=13 Participants
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
DKN-01 + Paclitaxel in Recurrent EOC
n=19 Participants
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 300mg Monotherapy in Carcinosarcoma
n=1 Participants
300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 600mg Monotherapy in Carcinosarcoma
n=8 Participants
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 300mg + Paclitaxel in Carcinosarcoma
n=4 Participants
300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 600mg + Paclitaxel in Carcinosarcoma
n=10 Participants
600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Number of Subjects With Objective Disease Control Rate (ODCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
11 Participants
12 Participants
6 Participants
13 Participants
1 Participants
1 Participants
1 Participants
5 Participants

SECONDARY outcome

Timeframe: Baseline to study completion (maximum 17.6 months)

Population: Full Analysis Set (FAS), all subjects who received any amount of DKN-01.

Overall Survival (OS) is defined as the time from first dose of study drug until date of death due to any cause.

Outcome measures

Outcome measures
Measure
DKN-01 Monotherapy in Recurrent EEC
n=29 Participants
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
DKN-01 + Paclitaxel in Recurrent EEC
n=24 Participants
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 Monotherapy in Recurrent EOC
n=14 Participants
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
DKN-01 + Paclitaxel in Recurrent EOC
n=19 Participants
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 300mg Monotherapy in Carcinosarcoma
n=1 Participants
300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 600mg Monotherapy in Carcinosarcoma
n=8 Participants
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 300mg + Paclitaxel in Carcinosarcoma
n=4 Participants
300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 600mg + Paclitaxel in Carcinosarcoma
n=12 Participants
600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Overall Survival (OS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
12.2 months
Interval 4.6 to
NA=Not Estimable. Data are not estimable due to insufficient number of participants with events.
10.1 months
Interval 6.5 to 13.6
10.8 months
Interval 5.7 to 17.6
11.9 months
Interval 6.6 to
NA=Not Estimable. Data are not estimable due to insufficient number of participants with events.
NA months
Data are not estimable due to insufficient number of participants with events.
8.4 months
Interval 1.3 to
NA=Not Estimable. Data are not estimable due to insufficient number of participants with events.
7.3 months
Interval 5.3 to
NA=Not Estimable. Data are not estimable due to insufficient number of participants with events.
5.7 months
Interval 1.6 to
NA=Not Estimable. Data are not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Baseline to study completion (maximum 7.1 months)

Population: Full Analysis Set (FAS), all subjects who received any amount of DKN-01.

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.

Outcome measures

Outcome measures
Measure
DKN-01 Monotherapy in Recurrent EEC
n=29 Participants
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
DKN-01 + Paclitaxel in Recurrent EEC
n=24 Participants
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 Monotherapy in Recurrent EOC
n=14 Participants
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
DKN-01 + Paclitaxel in Recurrent EOC
n=19 Participants
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 300mg Monotherapy in Carcinosarcoma
n=1 Participants
300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 600mg Monotherapy in Carcinosarcoma
n=8 Participants
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 300mg + Paclitaxel in Carcinosarcoma
n=4 Participants
300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 600mg + Paclitaxel in Carcinosarcoma
n=10 Participants
600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Progression-free Survival (PFS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
1.8 months
Interval 1.7 to 5.5
3.8 months
Interval 1.8 to 5.4
2.1 months
Interval 1.6 to 3.5
3.6 months
Interval 1.8 to 7.1
11.6 months
NA=not estimable. Data are not estimable due to insufficient number of participants with events.
1.6 months
Interval 0.5 to 7.9
2.0 months
Interval 1.8 to 5.5
1.9 months
Interval 0.9 to 4.0

SECONDARY outcome

Timeframe: Baseline to study completion (approximately 11 months)

Population: Number of participants analyzed only includes the responders in each group.

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.

Outcome measures

Outcome measures
Measure
DKN-01 Monotherapy in Recurrent EEC
n=2 Participants
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
DKN-01 + Paclitaxel in Recurrent EEC
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 Monotherapy in Recurrent EOC
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
DKN-01 + Paclitaxel in Recurrent EOC
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 300mg Monotherapy in Carcinosarcoma
300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 600mg Monotherapy in Carcinosarcoma
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 300mg + Paclitaxel in Carcinosarcoma
n=1 Participants
300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 600mg + Paclitaxel in Carcinosarcoma
n=1 Participants
600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Duration of Response (DoR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
NA months
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.
3.7 months
PR was reported for 1 subject with a progression event therefore no CIs are estimable
NA months
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.

SECONDARY outcome

Timeframe: Baseline to study completion (approximately 11 months)

Population: Number of participants analyzed only includes patients who have responded with an objective disease response (CR).

Number of participants analyzed only includes patients with a CR and is otherwise defined and analyzed similar to DoR.

Outcome measures

Outcome measures
Measure
DKN-01 Monotherapy in Recurrent EEC
n=1 Participants
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
DKN-01 + Paclitaxel in Recurrent EEC
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 Monotherapy in Recurrent EOC
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
DKN-01 + Paclitaxel in Recurrent EOC
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 300mg Monotherapy in Carcinosarcoma
300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 600mg Monotherapy in Carcinosarcoma
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 300mg + Paclitaxel in Carcinosarcoma
300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 600mg + Paclitaxel in Carcinosarcoma
600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Duration of Complete Response (DoCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
NA months
Insufficient number of participants with events.

SECONDARY outcome

Timeframe: Baseline to study completion (approximately 13.1 months)

Population: Number of participants analyzed only includes patients who had CR, PR, or SD.

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.

Outcome measures

Outcome measures
Measure
DKN-01 Monotherapy in Recurrent EEC
n=11 Participants
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
DKN-01 + Paclitaxel in Recurrent EEC
n=12 Participants
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 Monotherapy in Recurrent EOC
n=6 Participants
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
DKN-01 + Paclitaxel in Recurrent EOC
n=13 Participants
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 300mg Monotherapy in Carcinosarcoma
n=1 Participants
300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 600mg Monotherapy in Carcinosarcoma
n=1 Participants
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
DKN-01 300mg + Paclitaxel in Carcinosarcoma
n=1 Participants
300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
DKN-01 600mg + Paclitaxel in Carcinosarcoma
n=5 Participants
600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Duration of Clinical Benefit (DoCB) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
4.7 months
Interval 1.2 to 9.2
3.8 months
Interval 2.0 to 4.2
1.9 months
Interval 1.7 to 13.1
3.9 months
Interval 1.8 to 5.6
NA months
Subject had a progression event; the Kaplan-Meier estimated median duration of clinical benefit times was not estimable.
6.0 months
NA = not estimable. Data are not estimable due to insufficient number of participants with events.
3.7 months
NA = not estimable. Data are not estimable due to insufficient number of participants with events.
2.2 months
Interval 1.9 to
NE = not estimable. Data are not estimable due to insufficient number of participants with events.

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to study completion (approximately 6 months)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to study completion (approximately 6 months)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to study completion (approximately 6 months)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to study completion (approximately 6 months)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to study completion (approximately 6 months)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to study completion (approximately 6 months)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to study completion (approximately 6 months)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to study completion (approximately 6 months)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to study completion (approximately 6 months)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to study completion (approximately 6 months)

Outcome measures

Outcome data not reported

Adverse Events

DKN-01 Monotherapy in Recurrent EEC

Serious events: 8 serious events
Other events: 29 other events
Deaths: 14 deaths

DKN-01+Paclitaxel in Recurrent EEC

Serious events: 13 serious events
Other events: 24 other events
Deaths: 16 deaths

DKN-01 Monotherapy in Recurrent EOC

Serious events: 1 serious events
Other events: 13 other events
Deaths: 11 deaths

DKN-01+Paclitaxel in Recurrent EOC

Serious events: 6 serious events
Other events: 19 other events
Deaths: 12 deaths

300mg DKN-01 Monotherapy in Carcinosarcoma

Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths

600mg DKN-01 Monotherapy in Carcinosarcoma

Serious events: 2 serious events
Other events: 8 other events
Deaths: 4 deaths

300mg DKN-01+Paclitaxel in Carcinosarcoma

Serious events: 0 serious events
Other events: 4 other events
Deaths: 2 deaths

600mg DKN-01+Paclitaxel in Carcinosarcoma

Serious events: 6 serious events
Other events: 12 other events
Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure
DKN-01 Monotherapy in Recurrent EEC
n=29 participants at risk
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
DKN-01+Paclitaxel in Recurrent EEC
n=24 participants at risk
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 administered by IV infusion.
DKN-01 Monotherapy in Recurrent EOC
n=14 participants at risk
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
DKN-01+Paclitaxel in Recurrent EOC
n=19 participants at risk
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01and paclitaxel administered by IV infusion.
300mg DKN-01 Monotherapy in Carcinosarcoma
n=1 participants at risk
300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
600mg DKN-01 Monotherapy in Carcinosarcoma
n=8 participants at risk
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
300mg DKN-01+Paclitaxel in Carcinosarcoma
n=4 participants at risk
300mg DKN-01+paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
600mg DKN-01+Paclitaxel in Carcinosarcoma
n=12 participants at risk
600mg DKN-01+paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Blood and lymphatic system disorders
Anaemia
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Cardiac disorders
Sinus node dysfunction
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Cardiac disorders
Atrial fibrillation
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Nausea
6.9%
2/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Abdominal pain
3.4%
1/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Gastrointestinal haemorrhage
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Gastrointestinal perforation
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Large intestinal obstruction
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Vomiting
3.4%
1/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Ascites
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Gastrointestinal disorders
Colitis
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
General disorders
Oedema peripheral
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
General disorders
Non-cardiac chest pain
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
General disorders
Pyrexia
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Hepatobiliary disorders
Cholecystitis acute
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Urinary tract infection
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Infections and infestations
Abdominal abscess
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Sepsis
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Vulval abscess
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Catheter site cellulitis
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Infections and infestations
Upper respiratory tract infection
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Injury, poisoning and procedural complications
Fall
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Injury, poisoning and procedural complications
Post procedural bile leak
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Metabolism and nutrition disorders
Hypercalcaemia
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Metabolism and nutrition disorders
Hyperkalaemia
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Metabolism and nutrition disorders
Hyponatremia
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Renal and urinary disorders
Acute kidney injury
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Renal and urinary disorders
Urinary tract obstruction
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Nervous system disorders
Paraesthesia
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Nervous system disorders
Syncope
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Psychiatric disorders
Mania
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Renal and urinary disorders
Haematuria
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Renal and urinary disorders
Hydronephrosis
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
100.0%
1/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Vascular disorders
Deep vein thrombosis
0.00%
0/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Vascular disorders
Embolism
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.

Other adverse events

Other adverse events
Measure
DKN-01 Monotherapy in Recurrent EEC
n=29 participants at risk
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
DKN-01+Paclitaxel in Recurrent EEC
n=24 participants at risk
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 administered by IV infusion.
DKN-01 Monotherapy in Recurrent EOC
n=14 participants at risk
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
DKN-01+Paclitaxel in Recurrent EOC
n=19 participants at risk
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01and paclitaxel administered by IV infusion.
300mg DKN-01 Monotherapy in Carcinosarcoma
n=1 participants at risk
300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
600mg DKN-01 Monotherapy in Carcinosarcoma
n=8 participants at risk
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
300mg DKN-01+Paclitaxel in Carcinosarcoma
n=4 participants at risk
300mg DKN-01+paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
600mg DKN-01+Paclitaxel in Carcinosarcoma
n=12 participants at risk
600mg DKN-01+paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
Blood and lymphatic system disorders
Anaemia
24.1%
7/29 • 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 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.
54.2%
13/24 • 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 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.
14.3%
2/14 • 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 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.
15.8%
3/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
33.3%
4/12 • 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 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.
Blood and lymphatic system disorders
Neutropenia
3.4%
1/29 • 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 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.
20.8%
5/24 • 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 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.
7.1%
1/14 • 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 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.
26.3%
5/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
25.0%
1/4 • 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 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.
16.7%
2/12 • 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 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.
Blood and lymphatic system disorders
Thrombocytopenia
3.4%
1/29 • 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 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.
4.2%
1/24 • 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 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.
7.1%
1/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Blood and lymphatic system disorders
Abdominal lymphadenopathy
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Blood and lymphatic system disorders
Iron deficiency anaemia
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Blood and lymphatic system disorders
Leukopenia
3.4%
1/29 • 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 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.
16.7%
4/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
16.7%
2/12 • 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 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.
Blood and lymphatic system disorders
Lymphadenopathy
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Blood and lymphatic system disorders
Lymphopenia
3.4%
1/29 • 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 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.
20.8%
5/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Cardiac disorders
Tachycardia
6.9%
2/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
10.5%
2/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Cardiac disorders
Bradycardia
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Cardiac disorders
Sinus arrest
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Cardiac disorders
Sinus node dysfunction
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Cardiac disorders
Atrial fibrillation
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Cardiac disorders
Palpitations
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Cardiac disorders
Sinus tachycardia
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Ear and labyrinth disorders
Vertigo
6.9%
2/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Ear and labyrinth disorders
Deafness
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Ear and labyrinth disorders
Ear pain
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Eye disorders
Vision blurred
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Eye disorders
Dry eye
3.4%
1/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Eye disorders
Cataract
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Eye disorders
Conjunctival haemorrhage
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Eye disorders
Retinal tear
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Eye disorders
Vitreous haemorrhage
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Gastrointestinal disorders
Nausea
48.3%
14/29 • 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 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.
41.7%
10/24 • 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 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.
57.1%
8/14 • 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 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.
42.1%
8/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
50.0%
2/4 • 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 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.
33.3%
4/12 • 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 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.
Gastrointestinal disorders
Constipation
17.2%
5/29 • 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 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.
25.0%
6/24 • 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 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.
28.6%
4/14 • 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 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.
10.5%
2/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
25.0%
3/12 • 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 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.
Gastrointestinal disorders
Vomiting
24.1%
7/29 • 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 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.
25.0%
6/24 • 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 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.
14.3%
2/14 • 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 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.
26.3%
5/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
25.0%
1/4 • 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 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.
33.3%
4/12 • 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 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.
Gastrointestinal disorders
Abdominal pain
17.2%
5/29 • 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 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.
20.8%
5/24 • 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 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.
21.4%
3/14 • 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 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.
31.6%
6/19 • 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 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.
0.00%
0/1 • 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 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.
25.0%
2/8 • 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 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.
0.00%
0/4 • 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 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.
33.3%
4/12 • 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 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.
Gastrointestinal disorders
Abdominal distension
13.8%
4/29 • 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 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.
25.0%
6/24 • 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 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.
21.4%
3/14 • 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 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.
10.5%
2/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Gastrointestinal disorders
Diarrhoea
13.8%
4/29 • 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 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.
29.2%
7/24 • 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 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.
21.4%
3/14 • 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 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.
52.6%
10/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
25.0%
1/4 • 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 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.
8.3%
1/12 • 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 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.
Gastrointestinal disorders
Abdominal pain upper
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
16.7%
2/12 • 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 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.
Gastrointestinal disorders
Small intestinal obstruction
6.9%
2/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Abdominal hernia
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Abdominal tenderness
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Abdominal wall cyst
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Dry mouth
3.4%
1/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Dyspepsia
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
10.5%
2/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
25.0%
3/12 • 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 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.
Gastrointestinal disorders
Dysphagia
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Faecal incontinence
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Faeces discoloured
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Flatulence
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
10.5%
2/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Gastrointestinal haemorrhage
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Gastrointestinal perforation
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Gastrooesophageal reflux disease
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
25.0%
1/4 • 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 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.
25.0%
3/12 • 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 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.
Gastrointestinal disorders
Haemorrhoids
0.00%
0/29 • 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 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.
12.5%
3/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Intestinal obstruction
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Large intestinal obstruction
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Oral pain
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Proctalgia
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Stomatitis
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
15.8%
3/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Gastrointestinal disorders
Tooth impacted
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Ascites
0.00%
0/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
21.1%
4/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Anal haemorrhage
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Anorectal discomfort
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Colitis
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Epigastric discomfort
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Gastrointestinal disorders
Toothache
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Gastrointestinal disorders
Eructation
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Gastrointestinal disorders
Gastrointestinal pain
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Gastrointestinal disorders
Hiatus hernia
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
General disorders
Fatigue
44.8%
13/29 • 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 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.
45.8%
11/24 • 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 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.
64.3%
9/14 • 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 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.
36.8%
7/19 • 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 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.
0.00%
0/1 • 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 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.
25.0%
2/8 • 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 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.
0.00%
0/4 • 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 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.
58.3%
7/12 • 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 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.
General disorders
Oedema peripheral
13.8%
4/29 • 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 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.
33.3%
8/24 • 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 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.
0.00%
0/14 • 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 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.
21.1%
4/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
16.7%
2/12 • 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 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.
General disorders
Chills
6.9%
2/29 • 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 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.
12.5%
3/24 • 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 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.
0.00%
0/14 • 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 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.
10.5%
2/19 • 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 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.
100.0%
1/1 • 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 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.
12.5%
1/8 • 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 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.
25.0%
1/4 • 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 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.
0.00%
0/12 • 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 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.
General disorders
Pyrexia
6.9%
2/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
15.8%
3/19 • 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 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.
100.0%
1/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
General disorders
Asthenia
3.4%
1/29 • 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 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.
8.3%
2/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
General disorders
Gait disturbance
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
General disorders
Influenza like illness
3.4%
1/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
General disorders
Pain
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
General disorders
Generalised oedema
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
General disorders
Non-cardiac chest pain
0.00%
0/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
General disorders
Local swelling
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
General disorders
Localised oedema
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
General disorders
Thirst
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
General disorders
Catheter site hypersensitivity
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
General disorders
Medical device pain
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
General disorders
Medical device site pain
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
General disorders
Peripheral swelling
0.00%
0/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Hepatobiliary disorders
Hyperbilirubinaemia
10.3%
3/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Hepatobiliary disorders
Hepatic failure
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Hepatobiliary disorders
Cholecystitis acute
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Immune system disorders
Seasonal allergy
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0/0 • 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 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.
0/0 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Urinary tract infection
13.8%
4/29 • 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 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.
25.0%
6/24 • 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 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.
0.00%
0/14 • 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 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.
31.6%
6/19 • 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 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.
0.00%
0/1 • 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 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.
37.5%
3/8 • 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 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.
25.0%
1/4 • 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 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.
8.3%
1/12 • 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 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.
Infections and infestations
Sinusitis
10.3%
3/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Bronchitis
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
100.0%
1/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Upper respiratory tract infection
6.9%
2/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
15.8%
3/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
16.7%
2/12 • 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 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.
Infections and infestations
Fungal infection
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Hordeolum
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Nail infection
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Nasopharyngitis
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Oral candidiasis
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Pneumonia
3.4%
1/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Tooth infection
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Viral upper respiratory tract infection
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Cellulitis
0.00%
0/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Sepsis
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Infections and infestations
Abdominal abscess
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Candida infection
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Cystitis
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Localised infection
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Lung infection
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Infections and infestations
Otitis media
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Urinary tract infection eterococcal
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Vulval abscess
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Infections and infestations
Asymptomatic bacteriuria
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Infections and infestations
Catheter site cellulitis
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Infections and infestations
Vulvovaginal mycotic infection
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Injury, poisoning and procedural complications
Procedural pain
6.9%
2/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
100.0%
1/1 • 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 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.
0.00%
0/8 • 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 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.
25.0%
1/4 • 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 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.
8.3%
1/12 • 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 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.
Injury, poisoning and procedural complications
Excoriation
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Injury, poisoning and procedural complications
Fall
0.00%
0/29 • 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 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.
8.3%
2/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Injury, poisoning and procedural complications
Laceration
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Injury, poisoning and procedural complications
Meniscus injury
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Injury, poisoning and procedural complications
Nail injury
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Injury, poisoning and procedural complications
Stoma site pain
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Injury, poisoning and procedural complications
Vascular access complication
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Injury, poisoning and procedural complications
Animal scratch
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
25.0%
1/4 • 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 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.
8.3%
1/12 • 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 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.
Injury, poisoning and procedural complications
Contusion
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
25.0%
1/4 • 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 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.
0.00%
0/12 • 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 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.
Injury, poisoning and procedural complications
Compression fracture
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Injury, poisoning and procedural complications
Fracture
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Injury, poisoning and procedural complications
Head injury
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Injury, poisoning and procedural complications
Post procedural bile leak
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Injury, poisoning and procedural complications
Procedural headache
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Investigations
Aspartate aminotransferase increased
17.2%
5/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
16.7%
2/12 • 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 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.
Investigations
Alanine aminotransferase increased
13.8%
4/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
16.7%
2/12 • 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 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.
Investigations
Blood alkaline phosphatase increased
10.3%
3/29 • 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 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.
8.3%
2/24 • 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 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.
14.3%
2/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Investigations
Blood cholesterol increased
6.9%
2/29 • 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 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.
4.2%
1/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
16.7%
2/12 • 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 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.
Investigations
Blood creatinine increased
6.9%
2/29 • 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 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.
4.2%
1/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
16.7%
2/12 • 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 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.
Investigations
Blood lactate dehydrogenase increased
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
14.3%
2/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Investigations
Weight decreased
6.9%
2/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
16.7%
2/12 • 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 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.
Investigations
Amylase increased
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Investigations
Blood bilirubin increased
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Investigations
Blood creatine phosphokinase increased
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
16.7%
2/12 • 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 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.
Investigations
Gamma-glutamyltransferase increased
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Investigations
International normalised ratio increased
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Investigations
Lipase increased
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Investigations
Vitamin D decreased
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Investigations
Protein total decreased
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Investigations
Weight increased
0.00%
0/29 • 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 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.
12.5%
3/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Investigations
Activate partial thromboplastin time prolonged
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Investigations
Blood creatine increased
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Investigations
White blood cell count decreased
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Metabolism and nutrition disorders
Decreased appetite
17.2%
5/29 • 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 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.
20.8%
5/24 • 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 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.
14.3%
2/14 • 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 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.
10.5%
2/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
33.3%
4/12 • 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 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.
Metabolism and nutrition disorders
Hyperglycaemia
10.3%
3/29 • 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 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.
20.8%
5/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Metabolism and nutrition disorders
Hypokalaemia
10.3%
3/29 • 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 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.
16.7%
4/24 • 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 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.
7.1%
1/14 • 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 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.
15.8%
3/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
25.0%
1/4 • 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 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.
8.3%
1/12 • 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 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.
Metabolism and nutrition disorders
Hypomagnesaemia
10.3%
3/29 • 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 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.
16.7%
4/24 • 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 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.
7.1%
1/14 • 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 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.
15.8%
3/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
16.7%
2/12 • 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 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.
Metabolism and nutrition disorders
Hypophosphataemia
6.9%
2/29 • 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 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.
8.3%
2/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Metabolism and nutrition disorders
Hyperkalaemia
3.4%
1/29 • 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 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.
8.3%
2/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
25.0%
1/4 • 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 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.
8.3%
1/12 • 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 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.
Metabolism and nutrition disorders
Hyperuricaemia
3.4%
1/29 • 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 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.
4.2%
1/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Metabolism and nutrition disorders
Hypoalbuminaemia
6.9%
2/29 • 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 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.
12.5%
3/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Metabolism and nutrition disorders
Hyponatraemia
3.4%
1/29 • 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 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.
25.0%
6/24 • 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 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.
7.1%
1/14 • 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 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.
10.5%
2/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
33.3%
4/12 • 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 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.
Metabolism and nutrition disorders
Hypercalcaemia
3.4%
1/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Metabolism and nutrition disorders
Dehydration
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Metabolism and nutrition disorders
Appetite disorder
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Metabolism and nutrition disorders
Hypochloraemia
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Metabolism and nutrition disorders
Iron deficiency
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Metabolism and nutrition disorders
Type 1 diabetes mellitus
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Metabolism and nutrition disorders
Hypermagnesaemia
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Musculoskeletal and connective tissue disorders
Arthralgia
20.7%
6/29 • 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 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.
16.7%
4/24 • 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 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.
14.3%
2/14 • 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 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.
15.8%
3/19 • 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 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.
100.0%
1/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Musculoskeletal and connective tissue disorders
Back pain
10.3%
3/29 • 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 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.
29.2%
7/24 • 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 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.
14.3%
2/14 • 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 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.
0.00%
0/19 • 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 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.
100.0%
1/1 • 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 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.
25.0%
2/8 • 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 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.
0.00%
0/4 • 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 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.
16.7%
2/12 • 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 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.
Musculoskeletal and connective tissue disorders
Muscular weakness
10.3%
3/29 • 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 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.
0.00%
0/24 • 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 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.
14.3%
2/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
25.0%
1/4 • 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 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.
0.00%
0/12 • 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 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.
Musculoskeletal and connective tissue disorders
Muscle spasms
6.9%
2/29 • 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 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.
8.3%
2/24 • 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 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.
7.1%
1/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Musculoskeletal and connective tissue disorders
Myalgia
10.3%
3/29 • 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 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.
20.8%
5/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
25.0%
3/12 • 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 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.
Musculoskeletal and connective tissue disorders
Pain in extremity
3.4%
1/29 • 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 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.
12.5%
3/24 • 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 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.
14.3%
2/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
16.7%
2/12 • 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 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.
Musculoskeletal and connective tissue disorders
Bone pain
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Musculoskeletal and connective tissue disorders
Arthritis
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Musculoskeletal and connective tissue disorders
Bursitis
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Musculoskeletal and connective tissue disorders
Flank pain
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
25.0%
2/8 • 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 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.
25.0%
1/4 • 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 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.
0.00%
0/12 • 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 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.
Musculoskeletal and connective tissue disorders
Foot deformity
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Musculoskeletal and connective tissue disorders
Groin pain
3.4%
1/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Musculoskeletal and connective tissue disorders
Spinal column stenosis
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Musculoskeletal and connective tissue disorders
Joint swelling
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Musculoskeletal and connective tissue disorders
Osteopenia
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Musculoskeletal and connective tissue disorders
Pain in jaw
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0/0 • 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 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.
0.00%
0/12 • 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 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0/0 • 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 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.
0.00%
0/12 • 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 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Nervous system disorders
Headache
13.8%
4/29 • 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 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.
16.7%
4/24 • 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 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.
21.4%
3/14 • 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 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.
21.1%
4/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
16.7%
2/12 • 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 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.
Nervous system disorders
Dizziness
17.2%
5/29 • 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 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.
20.8%
5/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Nervous system disorders
Dysgeusia
10.3%
3/29 • 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 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.
25.0%
6/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Nervous system disorders
Neuropathy peripheral
6.9%
2/29 • 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 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.
16.7%
4/24 • 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 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.
7.1%
1/14 • 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 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.
15.8%
3/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
25.0%
3/12 • 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 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.
Nervous system disorders
Amnesia
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Nervous system disorders
Lethargy
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Nervous system disorders
Paraesthesia
0.00%
0/29 • 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 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.
8.3%
2/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Nervous system disorders
Parosmia
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Nervous system disorders
Tension headache
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Nervous system disorders
Tremor
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/29 • 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 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.
12.5%
3/24 • 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 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.
0.00%
0/14 • 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 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.
15.8%
3/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
25.0%
1/4 • 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 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.
8.3%
1/12 • 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 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.
Nervous system disorders
Aphasia
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Nervous system disorders
Memory impairment
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Nervous system disorders
Restless leg syndrome
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Nervous system disorders
Sedation
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Nervous system disorders
Sinus headache
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Nervous system disorders
Syncope
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Nervous system disorders
Somnolence
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Psychiatric disorders
Anxiety
3.4%
1/29 • 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 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.
8.3%
2/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Psychiatric disorders
Insomnia
6.9%
2/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
25.0%
1/4 • 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 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.
25.0%
3/12 • 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 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.
Psychiatric disorders
Confusional state
3.4%
1/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Psychiatric disorders
Depression
3.4%
1/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
16.7%
2/12 • 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 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.
Psychiatric disorders
Irritability
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Psychiatric disorders
Mania
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Renal and urinary disorders
Dysuria
10.3%
3/29 • 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 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.
12.5%
3/24 • 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 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.
7.1%
1/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Renal and urinary disorders
Haematuria
10.3%
3/29 • 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 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.
12.5%
3/24 • 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 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.
7.1%
1/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Renal and urinary disorders
Pollakiuria
10.3%
3/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
100.0%
1/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Renal and urinary disorders
Acute kidney injury
6.9%
2/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Renal and urinary disorders
Proteinuria
6.9%
2/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Renal and urinary disorders
Urinary hesitation
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Renal and urinary disorders
Urinary tract obstruction
6.9%
2/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Renal and urinary disorders
Chromaturia
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Renal and urinary disorders
Hypertonic bladder
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Renal and urinary disorders
Micturition urgency
3.4%
1/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Renal and urinary disorders
Nephrolithiasis
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Renal and urinary disorders
Urinary incontinence
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Renal and urinary disorders
Urinary retention
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Renal and urinary disorders
Urine odour abnormal
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Renal and urinary disorders
Bladder pain
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Renal and urinary disorders
Hydronephrosis
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Renal and urinary disorders
Renal failure
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Reproductive system and breast disorders
Vaginal haemorrhage
10.3%
3/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Reproductive system and breast disorders
Pelvic pain
6.9%
2/29 • 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 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.
12.5%
3/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Reproductive system and breast disorders
Vaginal discharge
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
7.1%
1/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Reproductive system and breast disorders
Vulvovaginal pain
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Reproductive system and breast disorders
Breast tenderness
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Reproductive system and breast disorders
Oedema genital
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
13.8%
4/29 • 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 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.
20.8%
5/24 • 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 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.
21.4%
3/14 • 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 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.
15.8%
3/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Cough
6.9%
2/29 • 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 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.
29.2%
7/24 • 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 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.
7.1%
1/14 • 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 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.
10.5%
2/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
25.0%
1/4 • 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 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.
8.3%
1/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Wheezing
10.3%
3/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
6.9%
2/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
3.4%
1/29 • 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 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.
4.2%
1/24 • 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 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.
7.1%
1/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Dysphonia
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
100.0%
1/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Sneezing
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
3.4%
1/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.00%
0/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Pleurisy
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Sinus congestion
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Skin and subcutaneous tissue disorders
Dry skin
6.9%
2/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Skin and subcutaneous tissue disorders
Night sweats
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Pruritus
6.9%
2/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Skin and subcutaneous tissue disorders
Rash
3.4%
1/29 • 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 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.
8.3%
2/24 • 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 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.
7.1%
1/14 • 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 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.
10.5%
2/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/29 • 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 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.
33.3%
8/24 • 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 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.
0.00%
0/14 • 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 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.
42.1%
8/19 • 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 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.
100.0%
1/1 • 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 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.
0.00%
0/8 • 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 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.
25.0%
1/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Dermatitis bullous
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Eczema
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Hyperhidrosis
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Ingrowing nail
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Nail ridging
3.4%
1/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Pain of skin
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
7.1%
1/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Skin ulcer
3.4%
1/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Skin and subcutaneous tissue disorders
Dermatitus allergic
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
25.0%
1/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Nail discoloration
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Nail disorder
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Onychoclasis
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Onycholysis
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Onychomadesis
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Rash macular
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Skin and subcutaneous tissue disorders
Cold sweat
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Skin and subcutaneous tissue disorders
Skin irritation
0.00%
0/29 • 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 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.
0.00%
0/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Surgical and medical procedures
Sinus operation
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Vascular disorders
Hypertension
10.3%
3/29 • 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 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.
12.5%
3/24 • 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 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.
7.1%
1/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Vascular disorders
Deep vein thrombosis
0.00%
0/29 • 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 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.
12.5%
3/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
100.0%
1/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Vascular disorders
Flushing
0.00%
0/29 • 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 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.
12.5%
3/24 • 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 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.
7.1%
1/14 • 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 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.
10.5%
2/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Vascular disorders
Hot flush
3.4%
1/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
10.5%
2/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Vascular disorders
Hypotension
3.4%
1/29 • 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 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.
12.5%
3/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
8.3%
1/12 • 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 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.
Vascular disorders
Haematoma
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
12.5%
1/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Vascular disorders
Embolism
0.00%
0/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
5.3%
1/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Vascular disorders
Lymphoedema
0.00%
0/29 • 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 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.
8.3%
2/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.
Vascular disorders
Thrombophlebitis superficial
0.00%
0/29 • 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 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.
4.2%
1/24 • 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 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.
0.00%
0/14 • 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 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.
0.00%
0/19 • 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 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.
0.00%
0/1 • 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 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.
0.00%
0/8 • 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 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.
0.00%
0/4 • 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 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.
0.00%
0/12 • 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 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.

Additional Information

Cynthia Sirard, MD, Chief Medical Officer

Leap Therapeutics, Inc.

Phone: +1-617-714-0360

Results disclosure agreements

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