Trial Outcomes & Findings for Nivolumab With or Without Ipilimumab in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (NCT NCT02498600)
NCT ID: NCT02498600
Last Updated: 2025-08-29
Results Overview
Complete and Partial Tumor Response by modified irRECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (irRECIST) 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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Within 6 months of study entry
Results posted on
2025-08-29
Participant Flow
The study opened to accrual on 6/29/2015 and enrolled 49 patients. It temporarily closed on 10/7/2015 and awaited data maturation until 10/4/2016. The study reopened on 5/22/2017 and closed 8/28/2017 with a cumulative accrual of 100 patients
Participant milestones
| Measure |
Treatment 1
Nivolumab: Nivolumab 3mg/kg IV once every 2 weeks x 4 doses (induction phase), followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.
1 Cycle = 4 weeks
|
Treatment II
Nivolumab/Ipilimumab: Nivolumab 3mg/kg IV and Ipilimumab 1mg/kg IV once every 3 weeks x 4 doses (induction phase)\*, followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.
1 Cycle = 3 weeks for induction phase
1 Cycle = 4 weeks for maintenance phase
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
|
Overall Study
COMPLETED
|
49
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab With or Without Ipilimumab in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
Treatment 1
n=49 Participants
Nivolumab: Nivolumab 3mg/kg IV once every 2 weeks x 4 doses (induction phase), followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.
1 Cycle = 4 weeks
|
Treatment II
n=51 Participants
Nivolumab/Ipilimumab: Nivolumab 3mg/kg IV and Ipilimumab 1mg/kg IV once every 3 weeks x 4 doses (induction phase)\*, followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.
1 Cycle = 3 weeks for induction phase
1 Cycle = 4 weeks for maintenance phase
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-49 years
|
7 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Age, Customized
50-59 ;years
|
10 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
|
Age, Customized
60-69 years
|
14 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
|
Age, Customized
>=70 years
|
18 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
29 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=39 Participants
|
51 Participants
n=41 Participants
|
100 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=39 Participants
|
50 Participants
n=41 Participants
|
94 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=39 Participants
|
43 Participants
n=41 Participants
|
86 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Within 6 months of study entryPopulation: All randomized patients
Complete and Partial Tumor Response by modified irRECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (irRECIST) 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 |
Treatment 1
n=49 Participants
Nivolumab: Nivolumab 3mg/kg IV once every 2 weeks x 4 doses (induction phase), followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.
1 Cycle = 4 weeks
|
Treatment II
n=51 Participants
Nivolumab/Ipilimumab: Nivolumab 3mg/kg IV and Ipilimumab 1mg/kg IV once every 3 weeks x 4 doses (induction phase)\*, followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.
1 Cycle = 3 weeks for induction phase
1 Cycle = 4 weeks for maintenance phase
|
|---|---|---|
|
Objective Tumor Response
|
12.2 percentage of participants
Interval 5.0 to 23.0
|
31.4 percentage of participants
Interval 21.0 to 44.0
|
SECONDARY outcome
Timeframe: The duration of time from study entry to time of progression or death, whichever occurs first, an average of 3.9 months.Population: All randomized patients
Time until disease progression, death, or date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (irRECIST), 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 |
Treatment 1
n=49 Participants
Nivolumab: Nivolumab 3mg/kg IV once every 2 weeks x 4 doses (induction phase), followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.
1 Cycle = 4 weeks
|
Treatment II
n=51 Participants
Nivolumab/Ipilimumab: Nivolumab 3mg/kg IV and Ipilimumab 1mg/kg IV once every 3 weeks x 4 doses (induction phase)\*, followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.
1 Cycle = 3 weeks for induction phase
1 Cycle = 4 weeks for maintenance phase
|
|---|---|---|
|
Progression-free Survival (PFS)
|
2.0 months
Interval 1.9 to 2.7
|
3.9 months
Interval 3.4 to 5.6
|
SECONDARY outcome
Timeframe: The duration of time from study entry to time of death or the date of last contact, assessed up to 5 yearsPopulation: All randomized patients
The observed length of life from randomization into the study to death or the date of last contact.
Outcome measures
| Measure |
Treatment 1
n=49 Participants
Nivolumab: Nivolumab 3mg/kg IV once every 2 weeks x 4 doses (induction phase), followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.
1 Cycle = 4 weeks
|
Treatment II
n=51 Participants
Nivolumab/Ipilimumab: Nivolumab 3mg/kg IV and Ipilimumab 1mg/kg IV once every 3 weeks x 4 doses (induction phase)\*, followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.
1 Cycle = 3 weeks for induction phase
1 Cycle = 4 weeks for maintenance phase
|
|---|---|---|
|
Duration of Overall Survival (OS)
|
21.8 months
Interval 8.9 to
Insufficient number of participants with events
|
28.1 months
Interval 12.6 to
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 30 days after treatment endsPopulation: All randomized patients.
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Outcome measures
| Measure |
Treatment 1
n=49 Participants
Nivolumab: Nivolumab 3mg/kg IV once every 2 weeks x 4 doses (induction phase), followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.
1 Cycle = 4 weeks
|
Treatment II
n=51 Participants
Nivolumab/Ipilimumab: Nivolumab 3mg/kg IV and Ipilimumab 1mg/kg IV once every 3 weeks x 4 doses (induction phase)\*, followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.
1 Cycle = 3 weeks for induction phase
1 Cycle = 4 weeks for maintenance phase
|
|---|---|---|
|
Incidence of Adverse Events Grade 3 and Above
|
52 number of adverse events
|
74 number of adverse events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineAssessed with immunohistochemistry.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineDetermined by the neo-epitope landscape using next-generation whole exome sequencing.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to after the first 8 weeks of therapyWill assess the impact of biomarkers on tumor response, PFS, and OS.
Outcome measures
Outcome data not reported
Adverse Events
Treatment 1
Serious events: 22 serious events
Other events: 48 other events
Deaths: 24 deaths
Treatment II
Serious events: 27 serious events
Other events: 51 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Treatment 1
n=49 participants at risk
Nivolumab: Nivolumab 3mg/kg IV once every 2 weeks x 4 doses (induction phase), followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.
1 Cycle = 4 weeks
|
Treatment II
n=51 participants at risk
Nivolumab/Ipilimumab: Nivolumab 3mg/kg IV and Ipilimumab 1mg/kg IV once every 3 weeks x 4 doses (induction phase)\*, followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.
1 Cycle = 3 weeks for induction phase
1 Cycle = 4 weeks for maintenance phase
|
|---|---|---|
|
Cardiac disorders
Cardiac Arrest
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Endocrine disorders
Endocrine Disorders - Other
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Nausea
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Pain
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Edema Face
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Death Nos
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Infusion Related Reaction
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Hepatobiliary disorders
Hepatic Hemorrhage
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Infections And Infestations - Other
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Serum Amylase Increased
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Platelet Count Decreased
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Lipase Increased
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.8%
4/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Aspartate Aminotransferase Increased
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Alanine Aminotransferase Increased
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Headache
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Ataxia
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Confusion
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.8%
4/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Social circumstances
Social Circumstances - Other
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Thromboembolic Event
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
Other adverse events
| Measure |
Treatment 1
n=49 participants at risk
Nivolumab: Nivolumab 3mg/kg IV once every 2 weeks x 4 doses (induction phase), followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.
1 Cycle = 4 weeks
|
Treatment II
n=51 participants at risk
Nivolumab/Ipilimumab: Nivolumab 3mg/kg IV and Ipilimumab 1mg/kg IV once every 3 weeks x 4 doses (induction phase)\*, followed by Nivolumab 3 mg/kg IV every 2 weeks (maintenance phase), for a maximum of 42 doses of maintenance therapy, until disease progression or until development of unacceptable toxicity, whichever comes first.
1 Cycle = 3 weeks for induction phase
1 Cycle = 4 weeks for maintenance phase
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemolytic Uremic Syndrome
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Blood and lymphatic system disorders
Anemia
|
40.8%
20/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
49.0%
25/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Cardiac Arrest
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Palpitations
|
6.1%
3/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Sinus Tachycardia
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Cardiac disorders
Chest Pain - Cardiac
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Ear and labyrinth disorders
Tinnitus
|
8.2%
4/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Ear and labyrinth disorders
Hearing Impaired
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Ear and labyrinth disorders
Ear Pain
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Endocrine disorders
Hypothyroidism
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
21.6%
11/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Endocrine disorders
Hyperthyroidism
|
6.1%
3/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
15.7%
8/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Watering Eyes
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Flashing Lights
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Eye Pain
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Glaucoma
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Blurred Vision
|
10.2%
5/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.7%
7/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Dry Eye
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
9.8%
5/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Floaters
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Eye disorders
Eyelid Function Disorder
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
3/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Dry Mouth
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
11.8%
6/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Colonic Stenosis
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Constipation
|
38.8%
19/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
47.1%
24/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Diarrhea
|
30.6%
15/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
41.2%
21/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Vomiting
|
20.4%
10/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
23.5%
12/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Upper Gastrointestinal Hemorrhage
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Bloating
|
8.2%
4/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.8%
4/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Stomach Pain
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Abdominal Pain
|
32.7%
16/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
41.2%
21/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Mucositis Oral
|
6.1%
3/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Abdominal Distension
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.8%
4/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Nausea
|
51.0%
25/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
52.9%
27/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
6.1%
3/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.7%
7/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Rectal Pain
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Fecal Incontinence
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Hemorrhoidal Hemorrhage
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Ascites
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Toothache
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.8%
4/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Pain
|
20.4%
10/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Neck Edema
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Malaise
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Irritability
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Flu Like Symptoms
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Non-Cardiac Chest Pain
|
6.1%
3/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Edema Limbs
|
10.2%
5/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
23.5%
12/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Edema Face
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Fatigue
|
65.3%
32/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
74.5%
38/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Fever
|
14.3%
7/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
21.6%
11/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Gait Disturbance
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Chills
|
6.1%
3/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Hypothermia
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
General disorders
Infusion Related Reaction
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Hepatobiliary disorders
Hepatic Hemorrhage
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Skin Infection
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Sepsis
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Meningitis
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Lung Infection
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Vaginal Infection
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Urinary Tract Infection
|
6.1%
3/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Catheter Related Infection
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Bronchial Infection
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Infections and infestations
Bladder Infection
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Radiation Recall Reaction (Dermatologic)
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Wound Complication
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Injury, poisoning and procedural complications
Bruising
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Weight Loss
|
10.2%
5/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.7%
7/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Serum Amylase Increased
|
10.2%
5/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
15.7%
8/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Platelet Count Decreased
|
14.3%
7/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.7%
7/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Lymphocyte Count Decreased
|
6.1%
3/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
11.8%
6/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Lipase Increased
|
18.4%
9/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.7%
7/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Inr Increased
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Creatinine Increased
|
14.3%
7/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
19.6%
10/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Cholesterol High
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Neutrophil Count Decreased
|
6.1%
3/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Carbon Monoxide Diffusing Capacity Decreased
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Blood Bilirubin Increased
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
White Blood Cell Decreased
|
18.4%
9/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
11.8%
6/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Aspartate Aminotransferase Increased
|
38.8%
19/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
31.4%
16/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Alkaline Phosphatase Increased
|
20.4%
10/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.7%
7/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Alanine Aminotransferase Increased
|
28.6%
14/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
21.6%
11/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders - Other
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Obesity
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.2%
6/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.4%
9/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
35.3%
18/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
34.7%
17/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
27.5%
14/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.2%
4/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
25.5%
13/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
7/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
21.6%
11/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
36.7%
18/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
39.2%
20/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.1%
3/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
11.8%
6/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
36.7%
18/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
41.2%
21/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
10.2%
5/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.8%
4/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Glucose Intolerance
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.8%
4/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Metabolism and nutrition disorders
Anorexia
|
20.4%
10/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
23.5%
12/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
8.2%
4/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
11.8%
6/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.2%
6/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
11.8%
6/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Upper Limb
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Joint Range Of Motion Decreased
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
12.2%
6/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.7%
7/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Buttock Pain
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
18.4%
9/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
25.5%
13/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.1%
3/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.8%
4/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.2%
5/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
11.8%
6/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Tremor
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Spasticity
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Somnolence
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Reversible Posterior Leukoencephalopathy Syndrome
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Presyncope
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
38.8%
19/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
37.3%
19/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Paresthesia
|
6.1%
3/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Memory Impairment
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Lethargy
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Intracranial Hemorrhage
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Headache
|
18.4%
9/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
29.4%
15/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Facial Nerve Disorder
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Facial Muscle Weakness
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Dysgeusia
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Sinus Pain
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Dizziness
|
14.3%
7/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.7%
7/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Concentration Impairment
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Ataxia
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Nervous system disorders
Akathisia
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Libido Decreased
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Insomnia
|
6.1%
3/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
17.6%
9/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Depression
|
20.4%
10/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.7%
7/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Confusion
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Anxiety
|
16.3%
8/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
9.8%
5/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Psychiatric disorders
Agitation
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Urine Discoloration
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Urinary Urgency
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Urinary Retention
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
9.8%
5/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Urinary Tract Pain
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Urinary Frequency
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Proteinuria
|
6.1%
3/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Hematuria
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Bladder Spasm
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Reproductive system and breast disorders
Vaginal Pain
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Reproductive system and breast disorders
Perineal Pain
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Reproductive system and breast disorders
Pelvic Pain
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.8%
4/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Reproductive system and breast disorders
Dyspareunia
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.8%
4/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.1%
3/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
9.8%
5/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
0.00%
0/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
32.7%
16/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
41.2%
21/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.5%
13/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
37.3%
19/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.8%
4/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
4.1%
2/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
5.9%
3/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.2%
4/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
29.4%
15/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
14.3%
7/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
37.3%
19/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
2.0%
1/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
11.8%
6/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.2%
4/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
9.8%
5/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Thromboembolic Event
|
6.1%
3/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
7.8%
4/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Hypotension
|
2.0%
1/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
3.9%
2/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Hypertension
|
12.2%
6/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
25.5%
13/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
|
Vascular disorders
Hot Flashes
|
8.2%
4/49 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
13.7%
7/51 • The average length of time adverse events were collected was 92 days.
Eligible and treated participants were affected if they experienced grade 1-5 adverse event
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60