Trial Outcomes & Findings for Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT01199263)
NCT ID: NCT01199263
Last Updated: 2020-09-16
Results Overview
Time from patient entry until progression, death, or date last seen. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
Approximately 4.5 years.
Results posted on
2020-09-16
Participant Flow
Participant milestones
| Measure |
Arm I (Paclitaxel)
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
|
Arm II (Paclitaxel and Wild-type Reovirus)
Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.
Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pelareorep: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
54
|
|
Overall Study
COMPLETED
|
48
|
52
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Arm I (Paclitaxel)
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
|
Arm II (Paclitaxel and Wild-type Reovirus)
Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.
Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pelareorep: Given IV
|
|---|---|---|
|
Overall Study
Ineligible
|
0
|
2
|
|
Overall Study
Never Treated
|
6
|
0
|
Baseline Characteristics
Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Paclitaxel)
n=54 Participants
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
|
Arm II (Paclitaxel and Wild-type Reovirus)
n=54 Participants
Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.
Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pelareorep: Given IV
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
30-39 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
20 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Customized
>=80 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 4.5 years.Population: Enrolled patients
Time from patient entry until progression, death, or date last seen. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Arm I (Paclitaxel)
n=54 Participants
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
|
Arm II (Paclitaxel and Wild-type Reovirus)
n=54 Participants
Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.
Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pelareorep: Given IV
|
|---|---|---|
|
Progression-free Survival (PFS)
|
3.94 Months
Interval 2.86 to 7.89
|
4.39 Months
Interval 2.6 to 5.52
|
PRIMARY outcome
Timeframe: approximately 4.5 yearsPopulation: Eligible and treated participants
The frequency and severity of Grade 3 and above toxicities are tabulated.
Outcome measures
| Measure |
Arm I (Paclitaxel)
n=48 Participants
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
|
Arm II (Paclitaxel and Wild-type Reovirus)
n=52 Participants
Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.
Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pelareorep: Given IV
|
|---|---|---|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Leukopenia
|
3 Participants
|
17 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Thrombocytopenia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Neutropenia
|
5 Participants
|
15 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Anemia
|
7 Participants
|
10 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Other Investigations
|
4 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Other Blood/lymphatics
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Cardiac
|
0 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Ear and Labyrinth
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Eye
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Nausea
|
4 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Vomiting
|
4 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Other gastrointestinal
|
18 Participants
|
16 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
General and administration site
|
5 Participants
|
13 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Hepatobiliary
|
0 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Infections/infestations
|
5 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Injury/poisoning
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Metabolism/nutrition
|
11 Participants
|
11 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Musculoskeletal/connective tissue
|
2 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Neoplasms benign/malignant
|
1 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Peripheral sensory neuropathy
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Nervous System
|
2 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Renal/urinary
|
2 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Reproductive/breast
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Respiratory/thoracic/mediastinal
|
1 Participants
|
13 Participants
|
|
Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0
Vascular disorders
|
11 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: approximately 4.5 yearsPopulation: All enrolled patients
Participants with Complete and Partial Tumor Response by RECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Arm I (Paclitaxel)
n=54 Participants
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
|
Arm II (Paclitaxel and Wild-type Reovirus)
n=54 Participants
Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.
Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pelareorep: Given IV
|
|---|---|---|
|
Percentage of Participants withTumor Response by RECIST
|
16.7 percentage of participants
Interval 7.9 to 29.3
|
13.0 percentage of participants
Interval 5.4 to 24.9
|
SECONDARY outcome
Timeframe: After patient stops protocol therapy, she is followed quarterly for 2 years, semi-annually for 3 more years, approximately 4.5 years.Population: Enrolled patients.
Time from patient randomization to death or date last seen.
Outcome measures
| Measure |
Arm I (Paclitaxel)
n=54 Participants
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
|
Arm II (Paclitaxel and Wild-type Reovirus)
n=54 Participants
Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.
Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pelareorep: Given IV
|
|---|---|---|
|
Median Overall Survival (OS) by Treatment Group
|
13.1 Months
Interval 7.9 to 21.4
|
12.6 Months
Interval 8.2 to 18.2
|
SECONDARY outcome
Timeframe: Before every cycle, approximately 4.5 years.Population: All enrolled patients.
Percentage of participants with Complete and Partial Tumor Response by CA125.
Outcome measures
| Measure |
Arm I (Paclitaxel)
n=54 Participants
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
|
Arm II (Paclitaxel and Wild-type Reovirus)
n=54 Participants
Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.
Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pelareorep: Given IV
|
|---|---|---|
|
Tumor Response by CA125
|
18.5 percentage of participants
Interval 9.3 to 31.4
|
22.2 percentage of participants
Interval 12.0 to 35.6
|
Adverse Events
Arm I (Paclitaxel)
Serious events: 17 serious events
Other events: 48 other events
Deaths: 0 deaths
Arm II (Paclitaxel and Wild-type Reovirus)
Serious events: 24 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Paclitaxel)
n=48 participants at risk
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
|
Arm II (Paclitaxel and Wild-type Reovirus)
n=52 participants at risk
Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.
Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pelareorep: Given IV
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Colonic Perforation
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
12.5%
6/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
7.7%
4/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Intra-Abdominal Hemorrhage
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Esophagitis
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Ascites
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
General disorders
Infusion Related Reaction
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Stoma Site Infection
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Skin Infection
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Sepsis
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Lung Infection
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
Creatinine Increased
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
5.8%
3/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
White Blood Cell Decreased
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
9.6%
5/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Syncope
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Vascular disorders
Thromboembolic Event
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Vascular disorders
Hypotension
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
Other adverse events
| Measure |
Arm I (Paclitaxel)
n=48 participants at risk
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
|
Arm II (Paclitaxel and Wild-type Reovirus)
n=52 participants at risk
Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.
Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Pelareorep: Given IV
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Blood and lymphatic system disorders
Anemia
|
89.6%
43/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
92.3%
48/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
9.6%
5/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Cardiac disorders
Palpitations
|
6.2%
3/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Cardiac disorders
Sinus Tachycardia
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
9.6%
5/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Cardiac disorders
Chest Pain - Cardiac
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Ear and labyrinth disorders
Tinnitus
|
12.5%
6/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Ear and labyrinth disorders
Hearing Impaired
|
6.2%
3/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Ear and labyrinth disorders
Ear Pain
|
8.3%
4/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Eye disorders
Watering Eyes
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Eye disorders
Flashing Lights
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Eye disorders
Eye Pain
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Eye disorders
Cataract
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Eye disorders
Conjunctivitis
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Eye disorders
Retinopathy
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Eye disorders
Blurred Vision
|
14.6%
7/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
11.5%
6/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Eye disorders
Floaters
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Eye disorders
Extraocular Muscle Paresis
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Dysphagia
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
7.7%
4/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
6/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Dry Mouth
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Colitis
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Constipation
|
58.3%
28/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
71.2%
37/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Diarrhea
|
41.7%
20/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
51.9%
27/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Vomiting
|
41.7%
20/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
46.2%
24/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Hemorrhage
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Bloating
|
20.8%
10/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
19.2%
10/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
5.8%
3/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Rectal Mucositis
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Abdominal Pain
|
47.9%
23/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
46.2%
24/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Mucositis Oral
|
20.8%
10/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
30.8%
16/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Oral Hemorrhage
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Ileus
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Oral Pain
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Abdominal Distension
|
14.6%
7/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
9.6%
5/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Nausea
|
72.9%
35/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
84.6%
44/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Rectal Pain
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Esophagitis
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Fecal Incontinence
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Ascites
|
10.4%
5/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
9.6%
5/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Toothache
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Anal Fistula
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Esophageal Pain
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Esophageal Hemorrhage
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Gastrointestinal disorders
Gastritis
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
General disorders
Pain
|
18.8%
9/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
40.4%
21/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
General disorders
Malaise
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
General disorders
Localized Edema
|
10.4%
5/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
5.8%
3/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
General disorders
Injection Site Reaction
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
General disorders
Infusion Site Extravasation
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
General disorders
Flu Like Symptoms
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
34.6%
18/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
General disorders
Edema Trunk
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
General disorders
Non-Cardiac Chest Pain
|
12.5%
6/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
15.4%
8/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
General disorders
Edema Limbs
|
37.5%
18/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
28.8%
15/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
General disorders
Facial Pain
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
General disorders
Edema Face
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
5.8%
3/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
General disorders
Fatigue
|
83.3%
40/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
84.6%
44/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
General disorders
Fever
|
14.6%
7/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
51.9%
27/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
General disorders
Gait Disturbance
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
General disorders
Chills
|
8.3%
4/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
63.5%
33/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
General disorders
Infusion Related Reaction
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Hepatobiliary disorders
Hepatobiliary Disorders - Other
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Hepatobiliary disorders
Gallbladder Pain
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Hepatobiliary disorders
Gallbladder Obstruction
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Immune system disorders
Allergic Reaction
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Upper Respiratory Infection
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Soft Tissue Infection
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Skin Infection
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Sinusitis
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
9.6%
5/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Sepsis
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Salivary Gland Infection
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Peritoneal Infection
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Otitis Media
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Papulopustular Rash
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Nail Infection
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Mucosal Infection
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Lung Infection
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Esophageal Infection
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Conjunctivitis Infective
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Gum Infection
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
5.8%
3/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Urinary Tract Infection
|
27.1%
13/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
21.2%
11/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Bronchial Infection
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Enterocolitis Infectious
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
5.8%
3/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Infections and infestations
Bladder Infection
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Injury, poisoning and procedural complications
Postoperative Hemorrhage
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
3/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Injury, poisoning and procedural complications
Bruising
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
Weight Loss
|
8.3%
4/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
7.7%
4/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
Weight Gain
|
8.3%
4/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
5.8%
3/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
Platelet Count Decreased
|
22.9%
11/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
57.7%
30/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
Lymphocyte Count Decreased
|
12.5%
6/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
7.7%
4/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
Inr Increased
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
5.8%
3/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
Creatinine Increased
|
27.1%
13/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
26.9%
14/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
Cholesterol High
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
Neutrophil Count Decreased
|
52.1%
25/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
75.0%
39/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
Urine Output Decreased
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
Blood Bilirubin Increased
|
6.2%
3/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
5.8%
3/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
White Blood Cell Decreased
|
72.9%
35/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
80.8%
42/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
Aspartate Aminotransferase Increased
|
22.9%
11/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
15.4%
8/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
Alkaline Phosphatase Increased
|
18.8%
9/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
15.4%
8/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
Alanine Aminotransferase Increased
|
14.6%
7/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
11.5%
6/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
8.3%
4/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
5.8%
3/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.2%
3/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
9.6%
5/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
31.2%
15/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
28.8%
15/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
22.9%
11/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
26.9%
14/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.8%
10/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
17.3%
9/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.2%
3/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
16/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
30.8%
16/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
43.8%
21/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
48.1%
25/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
8.3%
4/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
7.7%
4/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.2%
3/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
9.6%
5/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
35.4%
17/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
36.5%
19/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Dehydration
|
18.8%
9/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
13.5%
7/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Anorexia
|
45.8%
22/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
51.9%
27/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Metabolism and nutrition disorders
Acidosis
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
12.5%
6/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
13.5%
7/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
3/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
25.0%
13/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
18.8%
9/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
19.2%
10/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
8.3%
4/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
16.7%
8/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.7%
8/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
28.8%
15/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
12/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
19.2%
10/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Tremor
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
62.5%
30/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
63.5%
33/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Memory Impairment
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Movements Involuntary
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Headache
|
22.9%
11/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
36.5%
19/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Facial Muscle Weakness
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Dysphasia
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Dysgeusia
|
8.3%
4/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
5.8%
3/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Sinus Pain
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Syncope
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Dizziness
|
18.8%
9/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
23.1%
12/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Cognitive Disturbance
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Nervous system disorders
Akathisia
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Psychiatric disorders
Restlessness
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Psychiatric disorders
Insomnia
|
22.9%
11/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
23.1%
12/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Psychiatric disorders
Depression
|
37.5%
18/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
30.8%
16/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Psychiatric disorders
Confusion
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Psychiatric disorders
Anxiety
|
20.8%
10/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
21.2%
11/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Psychiatric disorders
Agitation
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Renal and urinary disorders
Urinary Urgency
|
10.4%
5/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Renal and urinary disorders
Urinary Retention
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Renal and urinary disorders
Urinary Incontinence
|
8.3%
4/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
7.7%
4/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
10.4%
5/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
11.5%
6/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Renal and urinary disorders
Urinary Frequency
|
16.7%
8/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
17.3%
9/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Renal and urinary disorders
Proteinuria
|
6.2%
3/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Renal and urinary disorders
Hematuria
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
5.8%
3/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Reproductive system and breast disorders
Vaginal Pain
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Reproductive system and breast disorders
Breast Pain
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
10.4%
5/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
5.8%
3/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Disorder
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
10.4%
5/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
7.7%
4/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
9.6%
5/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
14.6%
7/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
19.2%
10/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
9.6%
5/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
5.8%
3/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
7.7%
4/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnea
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
13.5%
7/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
24/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
57.7%
30/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
12/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
34.6%
18/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
10.4%
5/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
7.7%
4/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
6/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
15.4%
8/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Skin and subcutaneous tissue disorders
Pain Of Skin
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
20.8%
10/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
11.5%
6/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Skin and subcutaneous tissue disorders
Nail Ridging
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
8.3%
4/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
9.6%
5/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
10.4%
5/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
9.6%
5/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
3.8%
2/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
4.2%
2/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
9.6%
5/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Skin and subcutaneous tissue disorders
Bullous Dermatitis
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
0.00%
0/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
72.9%
35/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
69.2%
36/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Vascular disorders
Thromboembolic Event
|
8.3%
4/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
7.7%
4/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Vascular disorders
Superficial Thrombophlebitis
|
0.00%
0/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Vascular disorders
Lymphedema
|
2.1%
1/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
1.9%
1/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Vascular disorders
Hypotension
|
12.5%
6/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
13.5%
7/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Vascular disorders
Hypertension
|
31.2%
15/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
38.5%
20/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Vascular disorders
Hot Flashes
|
20.8%
10/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
13.5%
7/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
|
Vascular disorders
Flushing
|
8.3%
4/48 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
11.5%
6/52 • During study treatment (an average of 12 weeks) and up to 30 days after.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60