Trial Outcomes & Findings for A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer (NCT NCT03901469)
NCT ID: NCT03901469
Last Updated: 2025-10-07
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
115 participants
Primary outcome timeframe
Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months
Results posted on
2025-10-07
Participant Flow
The study was conducted at nineteen investigational sites in the United States (eight), Belgium (two), Spain (two), and China (seven) between June 2019 and March 2024
115 participants were enrolled and treated in the study.
Participant milestones
| Measure |
Part 1 Dose Escalation: Cohort 1
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort B - ZEN003694 Monotherapy
ZEN003694 48 mg PO QD as monotherapy at the in 28-day cycles with the option to cross-over to combination treatment of ZEN003694 48 mg PO QD with 0.75 mg Talazoparib PO QD at the time of disease progression (but no sooner than after 6 weeks of monotherapy). Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
3
|
42
|
21
|
3
|
32
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
3
|
42
|
21
|
3
|
32
|
Reasons for withdrawal
| Measure |
Part 1 Dose Escalation: Cohort 1
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort B - ZEN003694 Monotherapy
ZEN003694 48 mg PO QD as monotherapy at the in 28-day cycles with the option to cross-over to combination treatment of ZEN003694 48 mg PO QD with 0.75 mg Talazoparib PO QD at the time of disease progression (but no sooner than after 6 weeks of monotherapy). Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Radiographic Progression
|
4
|
6
|
3
|
30
|
7
|
2
|
11
|
|
Overall Study
Clinical Progression
|
0
|
2
|
0
|
7
|
6
|
0
|
2
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
9
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
0
|
8
|
|
Overall Study
Death
|
0
|
0
|
0
|
3
|
5
|
0
|
1
|
|
Overall Study
Termination of study by sponsor
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Not Reported
|
1
|
0
|
0
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Data not available for all study participants
Baseline characteristics by cohort
| Measure |
Part 1 Dose Escalation: Cohort 1
n=6 Participants
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
n=8 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
n=3 Participants
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
n=42 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients
n=21 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort B - ZEN003694 Monotherapy
n=3 Participants
ZEN003694 48 mg PO QD as monotherapy at the in 28-day cycles with the option to cross-over to combination treatment of ZEN003694 48 mg PO QD with 0.75 mg Talazoparib PO QD at the time of disease progression (but no sooner than after 6 weeks of monotherapy). Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
n=32 Participants
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55 years
n=6 Participants
|
53 years
n=8 Participants
|
57 years
n=3 Participants
|
51.5 years
n=42 Participants
|
49 years
n=21 Participants
|
50 years
n=3 Participants
|
55 years
n=32 Participants
|
52 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=6 Participants
|
8 Participants
n=8 Participants
|
3 Participants
n=3 Participants
|
42 Participants
n=42 Participants
|
21 Participants
n=21 Participants
|
3 Participants
n=3 Participants
|
32 Participants
n=32 Participants
|
115 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=6 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=32 Participants
|
6 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=6 Participants
|
7 Participants
n=8 Participants
|
2 Participants
n=3 Participants
|
40 Participants
n=42 Participants
|
18 Participants
n=21 Participants
|
3 Participants
n=3 Participants
|
20 Participants
n=32 Participants
|
95 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=3 Participants
|
12 Participants
n=32 Participants
|
14 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=3 Participants
|
31 Participants
n=32 Participants
|
34 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=32 Participants
|
5 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=6 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=3 Participants
|
38 Participants
n=42 Participants
|
14 Participants
n=21 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=32 Participants
|
68 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=32 Participants
|
8 Participants
n=115 Participants
|
|
Height
|
164.15 cm
n=6 Participants • Data not available for all study participants
|
166.35 cm
n=8 Participants • Data not available for all study participants
|
164.0 cm
n=3 Participants • Data not available for all study participants
|
164.5 cm
n=40 Participants • Data not available for all study participants
|
165.2 cm
n=18 Participants • Data not available for all study participants
|
175.2 cm
n=3 Participants • Data not available for all study participants
|
157.5 cm
n=32 Participants • Data not available for all study participants
|
162.5 cm
n=110 Participants • Data not available for all study participants
|
|
Weight
|
69.9 kg
n=6 Participants
|
72.9 kg
n=8 Participants
|
66.8 kg
n=3 Participants
|
66.0 kg
n=42 Participants
|
77.7 kg
n=21 Participants
|
64.5 kg
n=3 Participants
|
59.0 kg
n=32 Participants
|
65.4 kg
n=115 Participants
|
|
BMI
|
24.61 kg/m^2
n=6 Participants • Data not available for all study participants
|
27.65 kg/m^2
n=8 Participants • Data not available for all study participants
|
24.84 kg/m^2
n=3 Participants • Data not available for all study participants
|
25.90 kg/m^2
n=40 Participants • Data not available for all study participants
|
27.16 kg/m^2
n=18 Participants • Data not available for all study participants
|
21.70 kg/m^2
n=3 Participants • Data not available for all study participants
|
25.195 kg/m^2
n=32 Participants • Data not available for all study participants
|
25.57 kg/m^2
n=110 Participants • Data not available for all study participants
|
|
ECOG Performance Status
ECOG 0
|
4 Participants
n=6 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=3 Participants
|
26 Participants
n=42 Participants
|
14 Participants
n=21 Participants
|
1 Participants
n=3 Participants
|
15 Participants
n=32 Participants
|
66 Participants
n=115 Participants
|
|
ECOG Performance Status
ECOG 1
|
2 Participants
n=6 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=3 Participants
|
16 Participants
n=42 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=3 Participants
|
17 Participants
n=32 Participants
|
48 Participants
n=115 Participants
|
|
ECOG Performance Status
ECOG 2
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 monthsOutcome measures
| Measure |
Part 1 Dose Escalation: Cohort 1
n=6 Participants
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
n=8 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
n=3 Participants
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
n=42 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
|---|---|---|---|---|---|---|
|
Part 1 and Part 2: Number of Participants With Treatment-related Adverse Events (AE) and Treatment-related Serious Adverse Events (SAE)
Patients reporting at least one Serious TEAE related to study treatment
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Part 1 and Part 2: Number of Participants With Treatment-related Adverse Events (AE) and Treatment-related Serious Adverse Events (SAE)
Patients Reporting at least one TEAE related to study treatment
|
6 Participants
|
8 Participants
|
3 Participants
|
41 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1, Up to 1 monthDetermination of DLT will be made during the first 28 days of treatment (i.e., Cycle 1) in the dose escalation phase. A DLT is defined as a clinically significant AE or laboratory abnormality that is considered possibly, probably or definitely related to study drug.
Outcome measures
| Measure |
Part 1 Dose Escalation: Cohort 1
n=6 Participants
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
n=8 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
n=3 Participants
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Dose-limiting Toxicities (DLT)
Platelet count decreased
|
1 participants
|
1 participants
|
0 participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Dose-limiting Toxicities (DLT)
Platelet count decreased/ Fatigue
|
1 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From screening up to 18 monthsPopulation: Patients who have received at least 3 weeks of per-protocol treatment during Cycle 1, or \<3 weeks of treatment in Cycle 1 because of a DLT, will comprise the Efficacy Population. Patients who were determined to be "unevaluable" during Cycle 1 by the Sponsor and Investigator will not be included in the Efficacy Population.
Percentage of patients with a best overall response of confirmed complete response (CR), partial response (PR), or stable disease (SD ≥ 4 cycles) by RECIST v1.1
Outcome measures
| Measure |
Part 1 Dose Escalation: Cohort 1
n=37 Participants
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
|---|---|---|---|---|---|---|
|
Part 2: Clinical Benefit Rate (CBR)
|
32.4 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From screening up to 18 monthsPopulation: Patients who have received at least 3 weeks of per-protocol treatment during Cycle 1, or \<3 weeks of treatment in Cycle 1 because of a DLT, will comprise the Efficacy Population. Patients who were determined to be "unevaluable" during Cycle 1 by the Sponsor and Investigator will not be included in the Efficacy Population.
Percentage of participants with a confirmed complete response (CR) or partial response (PR) by RECIST 1.1
Outcome measures
| Measure |
Part 1 Dose Escalation: Cohort 1
n=14 Participants
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
|---|---|---|---|---|---|---|
|
Expansion Cohort A: Objective Response Rate (ORR) by RECIST v1.1 (CR or PR)
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From screening up to 18 monthsPopulation: Patients who have received at least 3 weeks of per-protocol treatment during Cycle 1, or \<3 weeks of treatment in Cycle 1 because of a DLT, will comprise the Efficacy Population. Patients who were determined to be "unevaluable" during Cycle 1 by the Sponsor and Investigator will not be included in the Efficacy Population.
Percentage of participants with a confirmed complete response (CR), partial response (PR), or stable disease (SD ≥ 4 cycles) by RECIST 1.1
Outcome measures
| Measure |
Part 1 Dose Escalation: Cohort 1
n=6 Participants
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
n=6 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
n=3 Participants
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
n=14 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
n=18 Participants
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
|---|---|---|---|---|---|---|
|
Part 1, Expansion Cohorts A and C: Clinical Benefit Rate (CBR)
|
33.3 Percentage of participants
|
66.7 Percentage of participants
|
33.3 Percentage of participants
|
0 Percentage of participants
|
11.1 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From screening up to 18 monthsPopulation: Patients who have received at least 3 weeks of per-protocol treatment during Cycle 1, or \<3 weeks of treatment in Cycle 1 because of a DLT, will comprise the Efficacy Population. Patients who were determined to be "unevaluable" during Cycle 1 by the Sponsor and Investigator will not be included in the Efficacy Population.
Percentage of participants with a confirmed complete response (CR) or partial response (PR) by RECIST 1.1
Outcome measures
| Measure |
Part 1 Dose Escalation: Cohort 1
n=6 Participants
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
n=6 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
n=3 Participants
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
n=37 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
n=18 Participants
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
|---|---|---|---|---|---|---|
|
Part 1, Part 2, and Expansion Cohort C: Objective Response Rate (ORR)
|
33.3 Percentage of participants
|
16.7 Percentage of participants
|
33.3 Percentage of participants
|
21.6 Percentage of participants
|
5.6 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From screening up to 18 monthsIncidence of Treatment-related Adverse Events (AE) and Treatment-related Serious Adverse Events (SAE) in Part 2, Expansion Cohorts A and C
Outcome measures
| Measure |
Part 1 Dose Escalation: Cohort 1
n=41 Participants
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
n=21 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
n=32 Participants
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
|---|---|---|---|---|---|---|
|
Part 2, Expansion Cohorts A and C: Safety Profile of ZEN003694 in Combination With Talazoparib.
Patients reporting at least one Serious TEAE related to study treatment
|
4 Participants
|
1 Participants
|
13 Participants
|
—
|
—
|
—
|
|
Part 2, Expansion Cohorts A and C: Safety Profile of ZEN003694 in Combination With Talazoparib.
Patients reporting at least one TEAE related to study treatment
|
41 Participants
|
19 Participants
|
32 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From screening up to 18 monthsPopulation: Patients who have received at least 3 weeks of per-protocol treatment during Cycle 1, or \<3 weeks of treatment in Cycle 1 because of a DLT, will comprise the Efficacy Population. Patients who were determined to be "unevaluable" during Cycle 1 by the Sponsor and Investigator will not be included in the Efficacy Population.
Median progression-free survival is the time from randomization to documented disease progression or death
Outcome measures
| Measure |
Part 1 Dose Escalation: Cohort 1
n=6 Participants
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
n=6 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
n=3 Participants
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
n=37 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
n=14 Participants
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
n=18 Participants
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
|---|---|---|---|---|---|---|
|
Part 1, Part 2, Expansion Cohorts A & C: Evaluate Median Progression-free Survival
|
5.42 months
Interval to 9.2
Insufficient sample size for software to calculate the lower confidence interval limit for median PFS
|
5.06 months
Insufficient sample size for software to calculate the lower and upper confidence interval limit for median PFS
|
1.51 months
Interval to 14.62
Insufficient sample size for software to calculate the lower confidence interval limit for median PFS
|
3.25 months
Interval 1.84 to 5.09
|
1.38 months
Interval 1.15 to 2.73
|
1.71 months
Interval 1.41 to 3.88
|
SECONDARY outcome
Timeframe: From screening up to 18 monthsPopulation: Participants with a confirmed response of PR or CR are included for the duration of response analysis
For subjects with a confirmed response of PR or CR, duration of response is measured from the date of the first response until the time that overall disease progression (radiographic progressive disease or clinical deterioration) or death is documented.
Outcome measures
| Measure |
Part 1 Dose Escalation: Cohort 1
n=8 Participants
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
n=1 Participants
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
|---|---|---|---|---|---|---|
|
Part 2, Expansion Cohorts A and C: Evaluate Duration of Response (DOR)
|
4.7 months
Interval 1.8 to 16.6
|
—
|
8.3 months
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Cycle 1 Day 1: Pre-dose, 15 min, 30 min, 1 hour, 2 hour, 4 hour, 6 hour, and 8 hours post-dose. Parts 1 & 2: Cycle 2 Day 1: Pre-dose, 1 hour, 2 hour, and 4 hours post-dose. (cycles are 28 days)Population: Part 1 (All evaluable participants): C1D1; Parts 1 \& 2 (All evaluable participants): C2D1
Cmax is defined as the maximum or peak plasma concentration of drug (calculated from samples taken over a 4-hour or 8-hour time period). Cmax(0-8h) was calculated for Cycle 1, Day 1. Cmax(0-4h) was calculated for Cycle 2, Day 1. Pre-dose is time 0 for calculations.
Outcome measures
| Measure |
Part 1 Dose Escalation: Cohort 1
n=6 Participants
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
n=8 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
n=3 Participants
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
n=28 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
|---|---|---|---|---|---|---|
|
Part 1 and Part 2: Measure the Pharmacokinetic Parameter (PK) of Cmax of ZEN003694 and ZEN003791 (Active Metabolite)
Cycle 1 Day 1 - ZEN003694
|
406 ng/ML
Standard Error 166
|
407 ng/ML
Standard Error 104
|
143 ng/ML
Standard Error 119
|
—
|
—
|
—
|
|
Part 1 and Part 2: Measure the Pharmacokinetic Parameter (PK) of Cmax of ZEN003694 and ZEN003791 (Active Metabolite)
Cycle 2 Day 1 - ZEN003694
|
217 ng/ML
Standard Error 154
|
465 ng/ML
Standard Error 158
|
401 ng/ML
Standard Error 174
|
513 ng/ML
Standard Error 196
|
—
|
—
|
|
Part 1 and Part 2: Measure the Pharmacokinetic Parameter (PK) of Cmax of ZEN003694 and ZEN003791 (Active Metabolite)
Cycle 2 Day 1 - ZEN003791
|
88 ng/ML
Standard Error 30
|
242 ng/ML
Standard Error 81
|
218 ng/ML
Standard Error 80
|
285 ng/ML
Standard Error 127
|
—
|
—
|
|
Part 1 and Part 2: Measure the Pharmacokinetic Parameter (PK) of Cmax of ZEN003694 and ZEN003791 (Active Metabolite)
Cycle 1 Day 1 - ZEN003791
|
202 ng/ML
Standard Error 60
|
187 ng/ML
Standard Error 65
|
66 ng/ML
Standard Error 30
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Cycle 1 Day 1: Pre-dose, 15 min, 30 min, 1 hour, 2 hour, 4 hour, 6 hour, and 8 hours post-dose. Parts 1 & 2: Cycle 2 Day 1: Pre-dose, 1 hour, 2 hour, and 4 hours post-dose. (cycles are 28 days)Population: Part 1 (All evaluable participants): C1D1; Parts 1 \& 2 (All evaluable participants): C2D1
AUC(0-4h or 0-8h) is defined as the area under the curve (plasma concentration of drug calculated from samples taken over a 4-hour or 8-hour time period). AUC(0-8h) was calculated for Cycle 1, Day 1. AUC(0-4h) was calculated for Cycle 2, Day 1. Pre-dose is time 0 for calculations.
Outcome measures
| Measure |
Part 1 Dose Escalation: Cohort 1
n=6 Participants
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
n=8 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
n=3 Participants
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
n=28 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
|---|---|---|---|---|---|---|
|
Part 1 and Part 2: Measure the Pharmacokinetic (PK) Parameter of Combined AUC(0-4h or 0-8h) of ZEN003694 and ZEN003791 (Active Metabolite)
AUC(0-4h) Cycle 2 Day 1
|
3067 ng*h/mL
Standard Error 1628
|
5615 ng*h/mL
Standard Error 696
|
7375 ng*h/mL
Standard Error 3818
|
1994 ng*h/mL
Standard Error 797
|
—
|
—
|
|
Part 1 and Part 2: Measure the Pharmacokinetic (PK) Parameter of Combined AUC(0-4h or 0-8h) of ZEN003694 and ZEN003791 (Active Metabolite)
AUC(0-8h) Cycle 1 Day 1
|
2680 ng*h/mL
Standard Error 894
|
2502 ng*h/mL
Standard Error 994
|
1013 ng*h/mL
Standard Error 733
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Cycle 1 Day 15: Pre-dose; Parts 1& 2 Cycle 2 Day 1: Pre-dose; Cycle 2 Day 15: Pre-dose (each cycle is 28 days)Population: Part 1 (All evaluable participants): C1D15; Parts 1 \& 2 (All evaluable participants): C2D1 \& C2D15
Plasma concentrations of talazoparib will be measured.
Outcome measures
| Measure |
Part 1 Dose Escalation: Cohort 1
n=6 Participants
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
n=5 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
n=3 Participants
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
n=35 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
|---|---|---|---|---|---|---|
|
Part 1 & 2: Measure Plasma Concentrations of Talazoparib.
Cycle 1 Day 15 Pre-dose
|
4813.3 pg/mL
Standard Deviation 2278.1
|
4582 pg/mL
Standard Deviation 1562.5
|
5650 pg/mL
Standard Deviation 2714.1
|
—
|
—
|
—
|
|
Part 1 & 2: Measure Plasma Concentrations of Talazoparib.
Cycle 2 Day 1 Pre-dose
|
3814 pg/mL
Standard Deviation 3092
|
3584.3 pg/mL
Standard Deviation 2819.4
|
8220 pg/mL
Standard Deviation 4073.1
|
3129.8 pg/mL
Standard Deviation 2190.2
|
—
|
—
|
|
Part 1 & 2: Measure Plasma Concentrations of Talazoparib.
Cycle 2 Day 15 Pre-dose
|
3952.5 pg/mL
Standard Deviation 1348.7
|
4892.5 pg/mL
Standard Deviation 1957.5
|
4840 pg/mL
Standard Deviation 3097.1
|
4240 pg/mL
Standard Deviation 2110.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1: Pre-dose, 1 hour, 2 hours, and 4 hours post-dose; Cycle 2 Day 15: Pre-dose (each cycle is 28 days)Population: Cohorts A and B - Study was terminated prior to PK analysis for samples collected from cohorts A and B, therefore data was not obtained. Data will never be obtained and reported for this measure. Cohort C - All Evaluable Participants.
Plasma concentrations of ZEN003694 and the active metabolite ZEN003791 will be measured.
Outcome measures
| Measure |
Part 1 Dose Escalation: Cohort 1
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
n=15 Participants
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
|---|---|---|---|---|---|---|
|
Expansion Cohorts A, B, and C: Measure Plasma Concentrations of ZEN003694 and the Active Metabolite ZEN003791.
ZEN003694 Cycle 2 Day 1 - 4 hours
|
—
|
—
|
345.3 ng/mL
Standard Deviation 116.9
|
—
|
—
|
—
|
|
Expansion Cohorts A, B, and C: Measure Plasma Concentrations of ZEN003694 and the Active Metabolite ZEN003791.
ZEN003694 Cycle 2 Day 15 - Predose
|
—
|
—
|
45.2 ng/mL
Standard Deviation 28.6
|
—
|
—
|
—
|
|
Expansion Cohorts A, B, and C: Measure Plasma Concentrations of ZEN003694 and the Active Metabolite ZEN003791.
ZEN003791 Cycle 2 Day 1 - Predose
|
—
|
—
|
110.2 ng/mL
Standard Deviation 84.3
|
—
|
—
|
—
|
|
Expansion Cohorts A, B, and C: Measure Plasma Concentrations of ZEN003694 and the Active Metabolite ZEN003791.
ZEN003694 Cycle 2 Day 1 - Predose
|
—
|
—
|
33.82 ng/mL
Standard Deviation 21.4
|
—
|
—
|
—
|
|
Expansion Cohorts A, B, and C: Measure Plasma Concentrations of ZEN003694 and the Active Metabolite ZEN003791.
ZEN003694 Cycle 2 Day 1 - 1 hour
|
—
|
—
|
383.9 ng/mL
Standard Deviation 259.1
|
—
|
—
|
—
|
|
Expansion Cohorts A, B, and C: Measure Plasma Concentrations of ZEN003694 and the Active Metabolite ZEN003791.
ZEN003694 Cycle 2 Day 1 - 2 hours
|
—
|
—
|
397.2 ng/mL
Standard Deviation 232.4
|
—
|
—
|
—
|
|
Expansion Cohorts A, B, and C: Measure Plasma Concentrations of ZEN003694 and the Active Metabolite ZEN003791.
ZEN003791 Cycle 2 Day 1 - 1 hour
|
—
|
—
|
231.0 ng/mL
Standard Deviation 158.9
|
—
|
—
|
—
|
|
Expansion Cohorts A, B, and C: Measure Plasma Concentrations of ZEN003694 and the Active Metabolite ZEN003791.
ZEN003791 Cycle 2 Day 1 - 2 hours
|
—
|
—
|
268.4 ng/mL
Standard Deviation 207.0
|
—
|
—
|
—
|
|
Expansion Cohorts A, B, and C: Measure Plasma Concentrations of ZEN003694 and the Active Metabolite ZEN003791.
ZEN003791 Cycle 2 Day 1 - 4 hours
|
—
|
—
|
303.8 ng/mL
Standard Deviation 154.1
|
—
|
—
|
—
|
|
Expansion Cohorts A, B, and C: Measure Plasma Concentrations of ZEN003694 and the Active Metabolite ZEN003791.
ZEN003791 Cycle 2 Day 15 - Predose
|
—
|
—
|
169.0 ng/mL
Standard Deviation 111.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1: Pre-dose, Cycle 2 Day 15: Pre-dose (each cycle is 28 days)Population: Cohorts A and B - Study was terminated prior to PK analysis for samples collected from cohorts A and B, therefore data was not obtained. Data will never be obtained and reported for this measure. Cohort C - All Evaluable Participants.
Plasma concentrations of talazoparib will be measured.
Outcome measures
| Measure |
Part 1 Dose Escalation: Cohort 1
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
n=15 Participants
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
|---|---|---|---|---|---|---|
|
Expansion Cohorts A and C: Measure Plasma Concentrations of Talazoparib.
Talazoparib Cycle 2 Day 1 - Pre-dose
|
—
|
2152.8 pg/mL
Standard Deviation 2031.9
|
—
|
—
|
—
|
—
|
|
Expansion Cohorts A and C: Measure Plasma Concentrations of Talazoparib.
Talazoparib Cycle 2 Day 15 - Pre-dose
|
—
|
4494.1 pg/mL
Standard Deviation 3139.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening and Day 1 of every 28-day Cycle, up to 18 months (Overall Duration)European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30): cancer-specific instrument with 30 questions to assess the participant QoL. First 28 questions used to evaluate 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, nausea and vomiting, pain) and other single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Each question assessed on 4-point scale (1= not at all, 2= a little, 3= quite a bit, 4= very much); functional scales: higher score = better level of functioning; symptom scale: higher score = more severe symptoms; for single items: higher score= more severe problem. Last 2 questions used to evaluate global health status (GHS)/QoL. Each question was assessed on 7-point scale (1= very poor to 7= excellent). Scores averaged, transformed to 0-100 scale; higher score=better quality of life/better level of functioning.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening and Day 1 of every 28-day Cycle, up to 18 months (Overall Duration)European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC-QLQ-BR23) is a disease-specific module for breast cancer developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer. EORTC-QLQ-BR23 symptoms subscale includes 4 items: systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss. Each item is rated by choosing 1 of 4 possible responses that record the level of intensity (1= not at all, 2= a little, 3= quite a bit, and 4= very much), higher scores=high level of symptom/problems.
Outcome measures
Outcome data not reported
Adverse Events
Part 1 Dose Escalation: Cohort 1
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1 Dose Escalation: Cohort 2
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 1 Dose Escalation: Cohort 3
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 Stages 1 & 2
Serious events: 11 serious events
Other events: 42 other events
Deaths: 3 deaths
Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients
Serious events: 10 serious events
Other events: 21 other events
Deaths: 5 deaths
Expansion Cohort B - ZEN003694 Monotherapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Expansion Cohort B - ZEN003694 Combination
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
Serious events: 14 serious events
Other events: 32 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Part 1 Dose Escalation: Cohort 1
n=6 participants at risk
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
n=8 participants at risk
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
n=3 participants at risk
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
n=42 participants at risk
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients
n=21 participants at risk
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort B - ZEN003694 Monotherapy
n=3 participants at risk
ZEN003694 48 mg PO QD as monotherapy at the in 28-day cycles with the option to cross-over to combination treatment of ZEN003694 48 mg PO QD with 0.75 mg Talazoparib PO QD at the time of disease progression (but no sooner than after 6 weeks of monotherapy). Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort B - ZEN003694 Combination
n=1 participants at risk
Post cross-over to combination treatment of ZEN003694 48 mg PO QD with 0.75 mg Talazoparib PO QD at the time of disease progression (but no sooner than after 6 weeks of monotherapy). Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
n=32 participants at risk
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
7.1%
3/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
2.4%
1/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
1/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
1/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
1/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
2.4%
1/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
6.2%
2/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
General disorders
Disease progression
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
2.4%
1/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
2.4%
1/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
2.4%
1/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Infections and infestations
Sepsis
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
21.9%
7/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
2.4%
1/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
2/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Nervous system disorders
Apraxia
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
2.4%
1/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Nervous system disorders
Haemorrhage intracranial
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
2.4%
1/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
2.4%
1/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
7.1%
3/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
14.3%
3/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
1/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
2.4%
1/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
2/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
2.4%
1/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
Other adverse events
| Measure |
Part 1 Dose Escalation: Cohort 1
n=6 participants at risk
ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 2
n=8 participants at risk
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 1 Dose Escalation: Cohort 3
n=3 participants at risk
ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Part 2 Stages 1 & 2
n=42 participants at risk
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients
n=21 participants at risk
ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort B - ZEN003694 Monotherapy
n=3 participants at risk
ZEN003694 48 mg PO QD as monotherapy at the in 28-day cycles with the option to cross-over to combination treatment of ZEN003694 48 mg PO QD with 0.75 mg Talazoparib PO QD at the time of disease progression (but no sooner than after 6 weeks of monotherapy). Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort B - ZEN003694 Combination
n=1 participants at risk
Post cross-over to combination treatment of ZEN003694 48 mg PO QD with 0.75 mg Talazoparib PO QD at the time of disease progression (but no sooner than after 6 weeks of monotherapy). Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
|
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
n=32 participants at risk
ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
2/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
1/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
6.2%
2/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Eye disorders
Dyschromatopsia
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
4/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Eye disorders
Photophobia
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
1/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
7.1%
3/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
2/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Eye disorders
Photopsia
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
1/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
1/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
21.4%
9/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
14.3%
3/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
1/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
6.2%
2/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
2/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
1/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
66.7%
2/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
19.0%
8/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
47.6%
10/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
50.0%
16/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
50.0%
3/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
1/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
1/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
19.0%
8/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
1/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
4/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
23.8%
5/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
21.9%
7/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
1/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
14.3%
6/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
4/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
37.5%
3/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
14.3%
6/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
23.8%
5/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
18.8%
6/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
1/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
14.3%
6/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
2/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
1/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
15.6%
5/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
2/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
2/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
14.3%
3/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.4%
3/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
2/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
2.4%
1/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
62.5%
5/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
45.2%
19/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
52.4%
11/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
59.4%
19/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
50.0%
4/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
26.2%
11/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
19.0%
4/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
1/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
40.6%
13/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
General disorders
Asthenia
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
1/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
1/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
4/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.4%
3/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
General disorders
Fatigue
|
66.7%
4/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
37.5%
3/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
1/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
14/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
61.9%
13/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
21.9%
7/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
General disorders
Malaise
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
18.8%
6/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
General disorders
Pain
|
33.3%
2/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
4/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
1/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
2/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.4%
3/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
25.0%
2/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
2.4%
1/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
2/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
37.5%
3/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
23.8%
10/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
14.3%
3/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
40.6%
13/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
37.5%
3/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
28.6%
12/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
23.8%
5/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
40.6%
13/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
1/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
2/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Investigations
Blood bilirubin increased
|
33.3%
2/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
2/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
78.1%
25/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Investigations
Blood creatinine increased
|
33.3%
2/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
1/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
11.9%
5/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
25.0%
8/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
2/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
19.0%
4/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
15.6%
5/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
1/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
2/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
18.8%
6/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
1/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
14.3%
6/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
14.3%
3/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
25.0%
8/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
25.0%
2/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
4/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
2/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
100.0%
1/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
37.5%
12/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Investigations
Platelet count decreased
|
50.0%
3/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
50.0%
4/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
38.1%
16/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
38.1%
8/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
1/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
100.0%
1/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
50.0%
16/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Investigations
Weight decreased
|
33.3%
2/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
1/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
1/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
2/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
18.8%
6/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Investigations
White blood cell count decreased
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
7.1%
3/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
37.5%
12/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
3/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
37.5%
3/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
1/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
26.2%
11/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
7/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
56.2%
18/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
1/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
15.6%
5/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
14.3%
6/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
38.1%
8/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
59.4%
19/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
1/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
2/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
2.4%
1/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
4/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
2/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
2/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
6.2%
2/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
18.8%
6/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
2.4%
1/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
14.3%
3/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.4%
3/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
2.4%
1/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
19.0%
4/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.4%
3/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
21.9%
7/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
2/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
14.3%
3/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
31.2%
10/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
2/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
1/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
2/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
23.8%
5/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
37.5%
12/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
7.1%
3/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
2/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
4/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
2/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
4/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
2/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
11.9%
5/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
23.8%
5/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
6.2%
2/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
7.1%
3/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
2/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
4/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
2/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.4%
3/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
1/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
1/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
21.4%
9/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
23.8%
5/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
11.9%
5/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
14.3%
3/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
12.5%
4/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
7.1%
3/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.5%
2/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Psychiatric disorders
Insomnia
|
33.3%
2/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
33.3%
1/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
2/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
1/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
9.4%
3/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
25.0%
2/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
2.4%
1/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
14.3%
3/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
15.6%
5/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
3/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
25.0%
2/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
11.9%
5/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
14.3%
3/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
6.2%
2/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
4.8%
2/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
37.5%
3/8 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
19.0%
8/42 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
14.3%
3/21 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/3 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
0.00%
0/1 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
3.1%
1/32 • Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.
Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure permission may only be granted upon sponsor review.
- Publication restrictions are in place
Restriction type: OTHER