Trial Outcomes & Findings for Gemcitabine Hydrochloride With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (NCT NCT02101775)
NCT ID: NCT02101775
Last Updated: 2025-09-29
Results Overview
To evaluate the progression free survival (PFS) of subjects with recurrent platinum-resistant ovarian, fallopian tube or primary peritoneal cancer receiving gemcitabine in combination with AZD1775 compared to subjects receiving gemcitabine in combination with placebo. Progression is defined, using the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guideline, as at least a 20% increase in the sum of the diameters of target lesions or the appearance of one or more new lesions.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
From start of treatment until date of progression or death, whichever occurs first, up to 1 year follow-up
Results posted on
2025-09-29
Participant Flow
Between Oct. 16, 2014 and Jan. 16, 2018, 124 women were enrolled, of whom 99 had high-grade serous ovarian cancer and were randomly assigned to AZD1775 plus gemcitabine (65 \[66%\]) or placebo plus gemcitabine (34 \[34%\]). 25 women with non-high-grade serous ovarian cancer were enrolled in the exploratory cohort.
After randomization, five patients with high-grade serous ovarian cancer were found to be ineligible (four in the experimental group and one in the control group) and did not receive treatment.
Participant milestones
| Measure |
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
Patients receive WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo, Gemcitabine Hydrochloride)
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Exploratory Cohort)
Patients with non-high-grade serous ovarian cancer. Patients receive WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
STARTED
|
65
|
34
|
25
|
|
Overall Study
COMPLETED
|
61
|
33
|
25
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
Patients receive WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo, Gemcitabine Hydrochloride)
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Exploratory Cohort)
Patients with non-high-grade serous ovarian cancer. Patients receive WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
0
|
|
Overall Study
Admission to Hospital
|
0
|
1
|
0
|
Baseline Characteristics
Gemcitabine Hydrochloride With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
n=61 Participants
Patients receive WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo, Gemcitabine Hydrochloride)
n=33 Participants
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine
n=25 Participants
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Age, Continuous
|
62 years
n=5 Participants
|
63 years
n=7 Participants
|
58 years
n=5 Participants
|
62 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
38 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until date of progression or death, whichever occurs first, up to 1 year follow-upTo evaluate the progression free survival (PFS) of subjects with recurrent platinum-resistant ovarian, fallopian tube or primary peritoneal cancer receiving gemcitabine in combination with AZD1775 compared to subjects receiving gemcitabine in combination with placebo. Progression is defined, using the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guideline, as at least a 20% increase in the sum of the diameters of target lesions or the appearance of one or more new lesions.
Outcome measures
| Measure |
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
n=61 Participants
Patients receive WEE1 inhibitor AZD-1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo, Gemcitabine Hydrochloride)
n=33 Participants
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine)
n=25 Participants
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Progression Free Survival
|
4.6 months
Interval 3.6 to 6.4
|
3.0 months
Interval 1.8 to 3.8
|
5.3 months
Interval 1.6 to 7.7
|
SECONDARY outcome
Timeframe: From start of treatment, every 6-8 weeks, until time of progression or death, whichever occurs first, up to 1 year follow-upTo evaluate the objective response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) of patients receiving gemcitabine combined with AZD1775 compared to patients receiving gemcitabine in combination with placebo. RECIST v1.1 criteria used for evaluation of target lesions: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions; Progressive Disease (PD), at least a 20% increase in the sum of the diameters of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. The Best Overall Response is the best response recorded from the start of the treatment until disease progression/recurrence .
Outcome measures
| Measure |
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
n=61 Participants
Patients receive WEE1 inhibitor AZD-1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo, Gemcitabine Hydrochloride)
n=33 Participants
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine)
n=25 Participants
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Objective Response
|
14 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From start of treatment, every 4 weeks, until time of progression or death, whichever occurs first, up to 1 year follow-upTo evaluate the GCIG CA125 response rate of patients receiving gemcitabine combined with AZD1775 compared to patients receiving gemcitabine in combination with placebo. A response according to CA-125 has occurred if there is at least a 50% reduction in CA-125 levels from a pre-treatment sample. The response must be confirmed and maintained for at least 28 days.
Outcome measures
| Measure |
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
n=61 Participants
Patients receive WEE1 inhibitor AZD-1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo, Gemcitabine Hydrochloride)
n=33 Participants
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine)
n=25 Participants
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Response According to CA125 Criteria
|
14 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment, every 12 weeks, until death, up to 22 months follow-upTo evaluate the overall survival of patients receiving gemcitabine combined with AZD1775 compared to patients receiving gemcitabine in combination with placebo.
Outcome measures
| Measure |
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
n=61 Participants
Patients receive WEE1 inhibitor AZD-1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo, Gemcitabine Hydrochloride)
n=33 Participants
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine)
n=25 Participants
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Survival
|
11.4 months
Interval 8.2 to 16.5
|
7.2 months
Interval 5.2 to 13.2
|
13 months
Interval 8.5 to 21.7
|
SECONDARY outcome
Timeframe: From start of treatment until AE resolution, stabilization, or improvement to less than grade 2, up to 1 year follow-upTo evaluate the safety and tolerability of the combination of gemcitabine combined with AZD1775 in patients with recurrent, platinum-resistant ovarian, fallopian tube or primary peritoneal cancer.
Outcome measures
| Measure |
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
n=61 Participants
Patients receive WEE1 inhibitor AZD-1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo, Gemcitabine Hydrochloride)
n=33 Participants
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine)
n=25 Participants
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Neutropenia
|
38 Participants
|
10 Participants
|
18 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Thrombocytopenia
|
19 Participants
|
2 Participants
|
9 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Fatigue
|
10 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Anemia
|
19 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Decreased White Blood Cell Count
|
33 Participants
|
6 Participants
|
16 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Decreased Lymphocyte Count
|
21 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Febrile Neutropenia
|
7 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Abdominal Pain
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Nausea
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Vomiting
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Edema Trunk
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Catheter Related Infection
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Sepsis
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Skin Infection
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Urinary Tract Infection
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Weight Gain
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Dehydration
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Hypokalemia
|
6 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Hyponatremia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Hypophosphatemia
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Dyspnea
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Pneumonitis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Hypertension
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Thromboembolic Event
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Alanine Aminotransferase Increased
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Aspartate Aminotransferase Increased
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Diarrhea
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Rash Maculo-Papular
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Hypoalbuminemia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Alkaline Phosphatase Increased
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Pruritis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Headache
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Syncope
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Anaphylaxis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Atrial Fibrillation
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Pneumonia
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Hematoma
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Wound Complication
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Fever
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Enterocolitis Infection
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Lung Infection
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: TP53 status was assessed in 108 patients. 8 patients had insufficient or unavailable samples and 3 patients were not tested.
To evaluate TP53 mutations (presence of mutation and type of mutation) as potential predictive factors of benefit (defined as response or PFS prolongation) to AZD1775 and gemcitabine treatment. TP53 status was assessed using Sanger sequencing.
Outcome measures
| Measure |
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
n=56 Participants
Patients receive WEE1 inhibitor AZD-1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo, Gemcitabine Hydrochloride)
n=33 Participants
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine)
n=19 Participants
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
TP53 Mutations
|
48 Participants
|
22 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: As per protocol, p53 protein expression was evaluated by immunohistochemistry to correlate with patients' mutational status of TP53
To evaluate p53 protein expression by immunohistochemistry as potential predictive factors of benefit (defined as response or PFS prolongation) to AZD1775 and gemcitabine treatment. Evaluating p53 expression in patients with high-grade serous ovarian cancer and in patients with high-grade serous ovarian cancer with TP53 mutations.
Outcome measures
| Measure |
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
n=88 Participants
Patients receive WEE1 inhibitor AZD-1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo, Gemcitabine Hydrochloride)
n=70 Participants
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine)
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
p53 Protein Expression
|
82 Participants
|
68 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: First 3 monthsWill be assessed using Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE). Each symptomatic AE is assessed with respect to 1 to 3 of the following attributes: frequency (F), severity (S) and/or interference (I) with usual or daily activities, and a recall period of 'the past 7 days'. PRO-CTCAE responses are scored from 0 to 4 with scores of 3 and 4 corresponding to high frequency, severity and/or interference. Results show the number of patients in each arm reporting high scores (3-4) for symptomatic AEs occurring in \>30% of patients
Outcome measures
| Measure |
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
n=28 Participants
Patients receive WEE1 inhibitor AZD-1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo, Gemcitabine Hydrochloride)
n=19 Participants
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine)
n=8 Participants
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Patient Reported Outcomes
Abdominal Pain F
|
10 Participants
|
9 Participants
|
1 Participants
|
|
Patient Reported Outcomes
Abdominal Pain S
|
9 Participants
|
5 Participants
|
0 Participants
|
|
Patient Reported Outcomes
Anxiety F
|
7 Participants
|
6 Participants
|
2 Participants
|
|
Patient Reported Outcomes
Bloating F
|
10 Participants
|
5 Participants
|
1 Participants
|
|
Patient Reported Outcomes
Bloating S
|
9 Participants
|
3 Participants
|
1 Participants
|
|
Patient Reported Outcomes
Fatigue S
|
16 Participants
|
6 Participants
|
4 Participants
|
|
Patient Reported Outcomes
Fatigue I
|
17 Participants
|
7 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Data were not collected
TP53 mutations in circulating tumor deoxyribonucleic acid will be evaluated by TAm-Seq.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 1 yearLevels of circulating deoxyribonucleic acid TP53 mutations will be correlated with response. \*No results for this outcome measure
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and at day 2 or 9 (course 1)Validation of pCDC2 as a pharmacodynamic marker of therapy. \*No results for this outcome measure
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and at day 2 or 9 (course 1)Validation of gH2AX as a pharmacodynamic marker of therapy. \*No results for this outcome measure
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and at day 2 or 9 (course 1)Changes in pCDC2 will be correlated with survival outcomes and response rate. \*No results for this outcome measure
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and at day 2 or 9 (course 1)Changes in pH2AX will be correlated with survival outcomes and response rate. \*No results for this outcome measure
Outcome measures
Outcome data not reported
Adverse Events
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
Serious events: 29 serious events
Other events: 61 other events
Deaths: 50 deaths
Arm II (Placebo, Gemcitabine Hydrochloride)
Serious events: 12 serious events
Other events: 33 other events
Deaths: 30 deaths
Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
Serious events: 10 serious events
Other events: 25 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
n=61 participants at risk
Patients receive WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo, Gemcitabine Hydrochloride)
n=33 participants at risk
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
n=25 participants at risk
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.9%
3/61 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
6.1%
2/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.6%
4/61 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.6%
4/61 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
6.1%
2/33 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Ascites
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Colonic Obstruction
|
3.3%
2/61 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Constipation
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Diarrhea
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Ileus
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Jejunal Obstruction
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Obstruction Gastric
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
6.6%
4/61 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
6.1%
2/33 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
General disorders
Edema Trunk
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
General disorders
Fatigue
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
General disorders
Fever
|
13.1%
8/61 • Number of events 9 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Infections and infestations
Abdominal Infection
|
3.3%
2/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Infections and infestations
Appendicitis Perforated
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Infections and infestations
Catheter Related Infection
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Infections and infestations
Sepsis
|
4.9%
3/61 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Infections and infestations
Skin Infection
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Infections and infestations
Urinary Tract Infection
|
6.6%
4/61 • Number of events 10 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
Cardiac Troponin I Increased
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
Lymphocyte Count Decreased
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
Neutrophil Count Decreased
|
11.5%
7/61 • Number of events 9 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
6.1%
2/33 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.0%
3/25 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
Platelet Count Decreased
|
8.2%
5/61 • Number of events 7 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
Weight Gain
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
White Blood Cell Decreased
|
9.8%
6/61 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Metabolism and nutrition disorders
Hypoatremia
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Left-Sided
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Nervous system disorders
Headache
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Blood and lymphatic system disorders
Right Leg Deep Vein Thrombosis
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.3%
2/61 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
2/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
General disorders
Treatment Hypersensitivity
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Vascular disorders
Hypertension
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Vascular disorders
Thromboembolic Event
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Infections and infestations
Cellulitis
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
General disorders
Death Due to Disease Progression
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
Other adverse events
| Measure |
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
n=61 participants at risk
Patients receive WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo, Gemcitabine Hydrochloride)
n=33 participants at risk
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
n=25 participants at risk
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
General disorders
Fatigue
|
88.5%
54/61 • Number of events 54 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
97.0%
32/33 • Number of events 32 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
80.0%
20/25 • Number of events 20 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Blood and lymphatic system disorders
Anemia
|
88.5%
54/61 • Number of events 54 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
90.9%
30/33 • Number of events 30 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
100.0%
25/25 • Number of events 25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Nausea
|
80.3%
49/61 • Number of events 49 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
72.7%
24/33 • Number of events 24 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
80.0%
20/25 • Number of events 20 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
Decreased white blood cell count
|
88.5%
54/61 • Number of events 54 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
69.7%
23/33 • Number of events 23 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
96.0%
24/25 • Number of events 24 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
Decreased platelet count (thrombocytopenia)
|
85.2%
52/61 • Number of events 52 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
66.7%
22/33 • Number of events 22 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
84.0%
21/25 • Number of events 21 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
Decreased neutrophil count (neutropenia)
|
82.0%
50/61 • Number of events 50 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
66.7%
22/33 • Number of events 22 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
92.0%
23/25 • Number of events 23 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
Decreased lymphocyte count
|
77.0%
47/61 • Number of events 47 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
66.7%
22/33 • Number of events 22 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
80.0%
20/25 • Number of events 20 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Abdominal pain
|
73.8%
45/61 • Number of events 45 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
66.7%
22/33 • Number of events 22 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
80.0%
20/25 • Number of events 20 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Constipation
|
70.5%
43/61 • Number of events 43 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
60.6%
20/33 • Number of events 20 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
80.0%
20/25 • Number of events 20 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
68.9%
42/61 • Number of events 42 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
66.7%
22/33 • Number of events 22 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
36.0%
9/25 • Number of events 9 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
Increased alanine aminotransferase
|
63.9%
39/61 • Number of events 39 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
66.7%
22/33 • Number of events 22 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
56.0%
14/25 • Number of events 14 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
Increased aspartate aminotransferase
|
62.3%
38/61 • Number of events 38 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
69.7%
23/33 • Number of events 23 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
56.0%
14/25 • Number of events 14 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Diarrhea
|
62.3%
38/61 • Number of events 38 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
42.4%
14/33 • Number of events 14 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
48.0%
12/25 • Number of events 12 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Vascular disorders
Hypertension
|
59.0%
36/61 • Number of events 36 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
42.4%
14/33 • Number of events 14 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
32.0%
8/25 • Number of events 8 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Vomiting
|
59.0%
36/61 • Number of events 36 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
30.3%
10/33 • Number of events 10 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
48.0%
12/25 • Number of events 12 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
General disorders
Fever
|
55.7%
34/61 • Number of events 34 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
42.4%
14/33 • Number of events 14 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
44.0%
11/25 • Number of events 11 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Metabolism and nutrition disorders
Anorexia
|
52.5%
32/61 • Number of events 32 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
54.5%
18/33 • Number of events 18 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
28.0%
7/25 • Number of events 7 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
49.2%
30/61 • Number of events 30 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
60.6%
20/33 • Number of events 20 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
32.0%
8/25 • Number of events 8 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Psychiatric disorders
Insomnia
|
44.3%
27/61 • Number of events 27 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
36.4%
12/33 • Number of events 12 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
40.0%
10/25 • Number of events 10 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
42.6%
26/61 • Number of events 26 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
42.4%
14/33 • Number of events 14 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
20.0%
5/25 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Metabolism and nutrition disorders
Hyponatremia
|
41.0%
25/61 • Number of events 25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
30.3%
10/33 • Number of events 10 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
52.0%
13/25 • Number of events 13 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
39.3%
24/61 • Number of events 24 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
39.4%
13/33 • Number of events 13 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
48.0%
12/25 • Number of events 12 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
39.3%
24/61 • Number of events 24 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
33.3%
11/33 • Number of events 11 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
24.0%
6/25 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
39.3%
24/61 • Number of events 24 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
44.0%
11/25 • Number of events 11 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
36.1%
22/61 • Number of events 22 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
21.2%
7/33 • Number of events 7 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
24.0%
6/25 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
General disorders
Chills
|
32.8%
20/61 • Number of events 20 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
30.3%
10/33 • Number of events 10 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
16.0%
4/25 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
32.8%
20/61 • Number of events 20 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
36.4%
12/33 • Number of events 12 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
24.0%
6/25 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
General disorders
Limb edema
|
32.8%
20/61 • Number of events 20 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
36.4%
12/33 • Number of events 12 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
28.0%
7/25 • Number of events 7 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
32.8%
20/61 • Number of events 20 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
15.2%
5/33 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Dyspepsia
|
31.1%
19/61 • Number of events 19 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
30.3%
10/33 • Number of events 10 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
20.0%
5/25 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Nervous system disorders
Headache
|
31.1%
19/61 • Number of events 19 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
39.4%
13/33 • Number of events 13 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
44.0%
11/25 • Number of events 11 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Metabolism and nutrition disorders
Hypokalemia
|
31.1%
19/61 • Number of events 19 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
40.0%
10/25 • Number of events 10 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
Weight loss
|
31.1%
19/61 • Number of events 19 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
24.2%
8/33 • Number of events 8 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
16.0%
4/25 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
Increased alkaline phosphatase
|
29.5%
18/61 • Number of events 18 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
33.3%
11/33 • Number of events 11 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
36.0%
9/25 • Number of events 9 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
29.5%
18/61 • Number of events 18 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
21.2%
7/33 • Number of events 7 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
32.0%
8/25 • Number of events 8 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
29.5%
18/61 • Number of events 18 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.1%
4/33 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
40.0%
10/25 • Number of events 10 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Psychiatric disorders
Anxiety
|
27.9%
17/61 • Number of events 17 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
27.3%
9/33 • Number of events 9 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
40.0%
10/25 • Number of events 10 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
27.9%
17/61 • Number of events 17 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
30.3%
10/33 • Number of events 10 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
20.0%
5/25 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Abdominal distension
|
19.7%
12/61 • Number of events 12 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
39.4%
13/33 • Number of events 13 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
16.0%
4/25 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Bloating
|
19.7%
12/61 • Number of events 12 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
33.3%
11/33 • Number of events 11 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
28.0%
7/25 • Number of events 7 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Vascular disorders
Thromboembolic event
|
16.4%
10/61 • Number of events 10 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
21.2%
7/33 • Number of events 7 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
20.0%
5/25 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.4%
10/61 • Number of events 10 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
21.2%
7/33 • Number of events 7 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
20.0%
5/25 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Metabolism and nutrition disorders
Dehydration
|
9.8%
6/61 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
6.1%
2/33 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
24.0%
6/25 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Nervous system disorders
Dizziness
|
24.6%
15/61 • Number of events 15 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
15.2%
5/33 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
24.0%
6/25 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Oral mucositis
|
24.6%
15/61 • Number of events 15 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.0%
3/25 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Infections and infestations
Urinary tract infection
|
23.0%
14/61 • Number of events 14 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.0%
3/25 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Renal and urinary disorders
Urinary frequency
|
19.7%
12/61 • Number of events 12 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.0%
3/25 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Nervous system disorders
Dysgeusia
|
19.7%
12/61 • Number of events 12 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
18.2%
6/33 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Ascites
|
19.7%
12/61 • Number of events 12 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
27.3%
9/33 • Number of events 9 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
16.0%
4/25 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Dry mouth
|
14.8%
9/61 • Number of events 9 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
General disorders
Pain
|
14.8%
9/61 • Number of events 9 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
Increased creatinine
|
14.8%
9/61 • Number of events 9 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
18.2%
6/33 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Psychiatric disorders
Depression
|
14.8%
9/61 • Number of events 9 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
18.2%
6/33 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
28.0%
7/25 • Number of events 7 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.1%
8/61 • Number of events 8 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
18.2%
6/33 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
20.0%
5/25 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Skin and subcutaneous tissue disorders
Acneiform rash
|
13.1%
8/61 • Number of events 8 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Cardiac disorders
Palpitations
|
13.1%
8/61 • Number of events 8 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.1%
8/61 • Number of events 8 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
6.1%
2/33 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
24.0%
6/25 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
13.1%
8/61 • Number of events 8 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.1%
4/33 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
20.0%
5/25 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
13.1%
8/61 • Number of events 8 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.5%
7/61 • Number of events 7 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
11.5%
7/61 • Number of events 7 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
21.2%
7/33 • Number of events 7 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Hemorrhoids
|
11.5%
7/61 • Number of events 7 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.0%
3/25 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.5%
7/61 • Number of events 7 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.0%
3/25 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.5%
7/61 • Number of events 7 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.1%
4/33 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.0%
3/25 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
Weight gain
|
11.5%
7/61 • Number of events 7 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.1%
4/33 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.8%
6/61 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
15.2%
5/33 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Flatulence
|
9.8%
6/61 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Vascular disorders
Flushing
|
9.8%
6/61 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.8%
6/61 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
15.2%
5/33 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Renal and urinary disorders
Urinary urgency
|
9.8%
6/61 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Cardiac disorders
Sinus tachycardia
|
9.8%
6/61 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.1%
4/33 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
General disorders
Flu like symptoms
|
9.8%
6/61 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
15.2%
5/33 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
16.0%
4/25 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Renal and urinary disorders
Urinary tract obstruction
|
9.8%
6/61 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.0%
3/25 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Eye disorders
Blurred vision
|
8.2%
5/61 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.1%
4/33 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
16.0%
4/25 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Nervous system disorders
Peripheral motor neuropathy
|
8.2%
5/61 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Reproductive system and breast disorders
Vaginal discharge
|
8.2%
5/61 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Renal and urinary disorders
Urinary incontinence
|
8.2%
5/61 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
8.2%
5/61 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.1%
4/33 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Renal and urinary disorders
Urinary tract pain
|
8.2%
5/61 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
6.1%
2/33 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.2%
5/61 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
8.2%
5/61 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Injury, poisoning and procedural complications
Bruising
|
6.6%
4/61 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Dysphagia
|
6.6%
4/61 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.6%
4/61 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
16.0%
4/25 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.6%
4/61 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.1%
4/33 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
16.0%
4/25 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
General disorders
Non-cardiac chest pain
|
6.6%
4/61 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.1%
4/33 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
6.6%
4/61 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
16.0%
4/25 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.9%
3/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
4.9%
3/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Vascular disorders
Hot flashes
|
4.9%
3/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
15.2%
5/33 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Nervous system disorders
Memory impairment
|
4.9%
3/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
6.1%
2/33 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Reproductive system and breast disorders
Pelvic pain
|
4.9%
3/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
15.2%
5/33 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.0%
3/25 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Ear and labyrinth disorders
Tinnitus
|
4.9%
3/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
6.1%
2/33 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Injury, poisoning and procedural complications
Wound complication
|
4.9%
3/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Eye disorders
Cataract
|
4.9%
3/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Injury, poisoning and procedural complications
Fall
|
4.9%
3/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
4.9%
3/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
Increase blood bilirubin
|
4.9%
3/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Vascular disorders
Hypotension
|
4.9%
3/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
General disorders
Malaise
|
4.9%
3/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Renal and urinary disorders
Proteinuria
|
4.9%
3/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Ear and labyrinth disorders
Hearing impaired
|
4.9%
3/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Endocrine disorders
Hypothyroidism
|
4.9%
3/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
20.0%
5/25 • Number of events 5 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Vascular disorders
Phlebitis
|
4.9%
3/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
6.1%
2/33 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Metabolism and nutrition disorders
Obesity
|
4.9%
3/61 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
3.0%
1/33 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Infections and infestations
Skin infection
|
3.3%
2/61 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
18.2%
6/33 • Number of events 6 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.0%
3/25 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.3%
2/61 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.1%
4/33 • Number of events 4 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.3%
2/61 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.3%
2/61 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.0%
3/25 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.3%
2/61 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
9.1%
3/33 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
6.1%
2/33 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
6.1%
2/33 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
General disorders
Localized edema
|
3.3%
2/61 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
6.1%
2/33 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.0%
3/25 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Vascular disorders
Lymphedema
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
6.1%
2/33 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Nervous system disorders
Tremor
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
6.1%
2/33 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
4.0%
1/25 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Vascular disorders
Hematoma
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
6.1%
2/33 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/25 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.3%
2/61 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.0%
3/25 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Ear and labyrinth disorders
Vertigo
|
3.3%
2/61 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.0%
3/25 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
Increased lymphocyte count
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
12.0%
3/25 • Number of events 3 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
General disorders
Injection site reaction
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.6%
1/61 • Number of events 1 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Infections and infestations
Sinusitis
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/61 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
0.00%
0/33 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
8.0%
2/25 • Number of events 2 • Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse events regularly assessed by Investigator
|
Additional Information
Dr. Amit Oza
University Health Network - Princess Margaret Cancer Centre
Phone: 416-946-4501
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60