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Trial Outcomes & Findings for Study of Pembrolizumab, Binimetinib, and Bevacizumab in Patients With Refractory Colorectal Cancer (NCT NCT03475004)

NCT ID: NCT03475004

Last Updated: 2024-09-19

Results Overview

Each study subject will be considered as a responder if their best CT imaging result is either CR (complete response) or PR (partial response) based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) evaluation criteria.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

53 participants

Primary outcome timeframe

Study beginning to study end; 12 months

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure
Other: Safety run-in
Ten patients will be accrued to stage 1 and treated with standard doses of pembrolizumab, binimetinib and bevacizumab. If the standard doses are not tolerable and 2 or more patients experience a DLT, then patients would be enrolled in dose level -1 which would comprise of standard doses of pembrolizumab and bevacizumab but binimetinib would be at a dose lower of 30 mg PO BID. If 2 or more patients experience a DLT at dose level-1, then patients will be enrolled in dose level -2 which will comprise of standard doses of pembrolizumab and bevacizumab but a lower dose of binimetinib at 15 mg BID. Upon determination of the safety and tolerability of the treatment regimen, the study will proceed to stage 2.
Experimental: Cohort A
Patients will start with 7-day run-in of binimetinib on day -7 of cycle 1 only. Pembrolizumab and bevacizumab will then be added to binimetinib on cycle 1 day +1. Cycle 1 will end on day 21. Patients will start treatment with pembrolizumab, binimetinib, and bevacizumab on day 1 of all subsequent cycles.
Experimental: Cohort B
Patients will be treated with pembrolizumab, bevacizumab, and binimetinib together on day 1 of all cycles including cycle 1. Patients will start treatment with pembrolizumab, binimetinib, and bevacizumab on day 1 of all subsequent cycles.
Overall Study
STARTED
11
21
21
Overall Study
COMPLETED
10
20
20
Overall Study
NOT COMPLETED
1
1
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Pembrolizumab, Binimetinib, and Bevacizumab in Patients With Refractory Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Safety run-in
n=11 Participants
Ten patients will be accrued to stage 1 and treated with standard doses of pembrolizumab, binimetinib and bevacizumab. If the standard doses are not tolerable and 2 or more patients experience a DLT, then patients would be enrolled in dose level -1 which would comprise of standard doses of pembrolizumab and bevacizumab but binimetinib would be at a dose lower of 30 mg PO BID. If 2 or more patients experience a DLT at dose level-1, then patients will be enrolled in dose level -2 which will comprise of standard doses of pembrolizumab and bevacizumab but a lower dose of binimetinib at 15 mg BID. Upon determination of the safety and tolerability of the treatment regimen, the study will proceed to stage 2.
Cohort A
n=21 Participants
Patients will start with 7-day run-in of binimetinib on day -7 of cycle 1 only. Pembrolizumab and bevacizumab will then be added to binimetinib on cycle 1 day +1. Cycle 1 will end on day 21. Patients will start treatment with pembrolizumab, binimetinib, and bevacizumab on day 1 of all subsequent cycles.
Cohort B
n=21 Participants
Patients will be treated with pembrolizumab, bevacizumab, and binimetinib together on day 1 of all cycles including cycle 1. Patients will start treatment with pembrolizumab, binimetinib, and bevacizumab on day 1 of all subsequent cycles.
Total
n=53 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
n=5 Participants
16 Participants
n=7 Participants
20 Participants
n=5 Participants
43 Participants
n=4 Participants
Age, Categorical
>=65 years
4 Participants
n=5 Participants
5 Participants
n=7 Participants
1 Participants
n=5 Participants
10 Participants
n=4 Participants
Age, Continuous
56 years
STANDARD_DEVIATION 11.4 • n=5 Participants
52 years
STANDARD_DEVIATION 13.1 • n=7 Participants
53 years
STANDARD_DEVIATION 9.8 • n=5 Participants
53.9 years
STANDARD_DEVIATION 11.4 • n=4 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
14 Participants
n=7 Participants
7 Participants
n=5 Participants
26 Participants
n=4 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
7 Participants
n=7 Participants
14 Participants
n=5 Participants
27 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
2 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants
n=5 Participants
19 Participants
n=7 Participants
21 Participants
n=5 Participants
51 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
Asian
2 Participants
n=5 Participants
2 Participants
n=7 Participants
1 Participants
n=5 Participants
5 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
White
7 Participants
n=5 Participants
18 Participants
n=7 Participants
18 Participants
n=5 Participants
43 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
3 Participants
n=4 Participants
Region of Enrollment
United States
11 participants
n=5 Participants
21 participants
n=7 Participants
21 participants
n=5 Participants
53 participants
n=4 Participants

PRIMARY outcome

Timeframe: Study beginning to study end; 12 months

Population: All eligible subjects with response data

Each study subject will be considered as a responder if their best CT imaging result is either CR (complete response) or PR (partial response) based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) evaluation criteria.

Outcome measures

Outcome measures
Measure
Safety Run-In
n=9 Participants
Phase 1: Triplet tx w/o run-in of binimetinib (see 'Arms and Interventions' description in Protocol Section)
Cohort A
n=18 Participants
Phase 2: Triplex tx with 7-day run-in of binimetinib (see 'Arms and Interventions' in Protocol Section)
Cohort B
n=18 Participants
Phase 2: Triplex tx w/o 7-day run-in of binimetinib (see 'Arms and Interventions' of Protocol Section)
Objective Response
1 Participants
3 Participants
2 Participants

SECONDARY outcome

Timeframe: Study start date to first sign of disease progression or death, whichever comes first.

Population: All patients who had follow-up data. Among the 50 total subjects, subjects 11, 19, 32, 33, and 53 did not have follow-up data. This resulted in 45 subjects being included in the PFS analysis.

The median progression-free survival was calculated using the Kaplan-Meier product-limit method.

Outcome measures

Outcome measures
Measure
Safety Run-In
n=9 Participants
Phase 1: Triplet tx w/o run-in of binimetinib (see 'Arms and Interventions' description in Protocol Section)
Cohort A
n=18 Participants
Phase 2: Triplex tx with 7-day run-in of binimetinib (see 'Arms and Interventions' in Protocol Section)
Cohort B
n=18 Participants
Phase 2: Triplex tx w/o 7-day run-in of binimetinib (see 'Arms and Interventions' of Protocol Section)
Progression-Free Survival (PFS)
8.7 Months
Interval 2.2 to
The upper limit of this 95% CI is infinity (and the entry 'Infinity' cannot be made)
7.6 Months
Interval 2.8 to
The upper limit of this 95% CI is infinity (and the entry 'Infinity' cannot be made)
5.8 Months
Interval 2.8 to 6.9

SECONDARY outcome

Timeframe: Time (measured in months) from each subject starting treatment until either death (from any cause) or being censored at their last contact.

Population: All 50 subjects enrolled onto the trial.

OS is defined as the time (measured in months) from each subject starting treatment until either death (from any cause) or being censored at their last contact.

Outcome measures

Outcome measures
Measure
Safety Run-In
n=10 Participants
Phase 1: Triplet tx w/o run-in of binimetinib (see 'Arms and Interventions' description in Protocol Section)
Cohort A
n=20 Participants
Phase 2: Triplex tx with 7-day run-in of binimetinib (see 'Arms and Interventions' in Protocol Section)
Cohort B
n=20 Participants
Phase 2: Triplex tx w/o 7-day run-in of binimetinib (see 'Arms and Interventions' of Protocol Section)
Overall Survival (OS)
12.6 Months-to-Death
Interval 1.9 to 20.7
9.3 Months-to-Death
Interval 4.5 to
The upper limit of this 95% CI is infinity (and the entry 'Infinity' cannot be made)
8.5 Months-to-Death
Interval 5.9 to 10.7

SECONDARY outcome

Timeframe: Study beginning to study end, 12 months

Population: Adverse events from all subjects were evaluated.

Grade 1, 2, 3, 4, or 5 adverse events (AE) as defined by CTCAE v4 were summarized. All adverse events summarized were non-baseline AEs (i.e. each AE was not present at baseline). AEs were summarized by generating counts of AEs by AE description and severity, but no formal statistical test was performed on the AEs. For the purpose of this section, the outcome measure will be defined as the number of subjects who had at least 1 AE.

Outcome measures

Outcome measures
Measure
Safety Run-In
n=10 Participants
Phase 1: Triplet tx w/o run-in of binimetinib (see 'Arms and Interventions' description in Protocol Section)
Cohort A
n=20 Participants
Phase 2: Triplex tx with 7-day run-in of binimetinib (see 'Arms and Interventions' in Protocol Section)
Cohort B
n=20 Participants
Phase 2: Triplex tx w/o 7-day run-in of binimetinib (see 'Arms and Interventions' of Protocol Section)
Adverse Events
10 Participants
20 Participants
20 Participants

Adverse Events

Safety run-in

Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths

Cohort A

Serious events: 11 serious events
Other events: 21 other events
Deaths: 4 deaths

Cohort B

Serious events: 8 serious events
Other events: 21 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Safety run-in
n=11 participants at risk
Ten patients will be accrued to stage 1 and treated with standard doses of pembrolizumab, binimetinib and bevacizumab. If the standard doses are not tolerable and 2 or more patients experience a DLT, then patients would be enrolled in dose level -1 which would comprise of standard doses of pembrolizumab and bevacizumab but binimetinib would be at a dose lower of 30 mg PO BID. If 2 or more patients experience a DLT at dose level-1, then patients will be enrolled in dose level -2 which will comprise of standard doses of pembrolizumab and bevacizumab but a lower dose of binimetinib at 15 mg BID. Upon determination of the safety and tolerability of the treatment regimen, the study will proceed to stage 2.
Cohort A
n=21 participants at risk
Patients will start with 7-day run-in of binimetinib on day -7 of cycle 1 only. Pembrolizumab and bevacizumab will then be added to binimetinib on cycle 1 day +1. Cycle 1 will end on day 21. Patients will start treatment with pembrolizumab, binimetinib, and bevacizumab on day 1 of all subsequent cycles.
Cohort B
n=21 participants at risk
Patients will be treated with pembrolizumab, bevacizumab, and binimetinib together on day 1 of all cycles including cycle 1. Patients will start treatment with pembrolizumab, binimetinib, and bevacizumab on day 1 of all subsequent cycles.
Blood and lymphatic system disorders
Dehydration
9.1%
1/11 • Number of events 2 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Blood and lymphatic system disorders
Hypokalemia
9.1%
1/11 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Leg Pain
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Gastrointestinal disorders
Colon Perforation
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary Hemorrhage
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
General disorders
Confusion
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Infections and infestations
Hepatitis
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Blood and lymphatic system disorders
alanine aminotransferase increase
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Blood and lymphatic system disorders
Aspartate Aminotransferase Increased
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Nausea
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Death
0.00%
0/11 • 3 years, 4 months
19.0%
4/21 • Number of events 4 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Respiratory, thoracic and mediastinal disorders
Lung Infection
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
General disorders
Disease Progression
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Abdominal Pain
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Gastrointestinal disorders
Diarrhea
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Gastrointestinal disorders
Colonic Obstruction
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Renal and urinary disorders
Urinary Tract Infection
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Blood and lymphatic system disorders
Hyperbilirubinemia
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Lethargy
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Gastrointestinal disorders
Upper Gastrointestinal hemorrhage
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Infections and infestations
Sepsis
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Infections and infestations
Cholangitis
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Infections and infestations
Pancreatitis
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Cardiac disorders
Sinus Bradycardia
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Syncope
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Blood and lymphatic system disorders
Intracranial Hemorrhage
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Gastrointestinal disorders
Small Bowel Obstruction
0.00%
0/11 • 3 years, 4 months
9.5%
2/21 • Number of events 2 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Gastrointestinal disorders
Constipation
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Blood and lymphatic system disorders
Hypophosphatemia
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Dysphagia
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Psychiatric disorders
Depression
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Musculoskeletal and connective tissue disorders
Rib pain
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Musculoskeletal and connective tissue disorders
Back Pain
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months

Other adverse events

Other adverse events
Measure
Safety run-in
n=11 participants at risk
Ten patients will be accrued to stage 1 and treated with standard doses of pembrolizumab, binimetinib and bevacizumab. If the standard doses are not tolerable and 2 or more patients experience a DLT, then patients would be enrolled in dose level -1 which would comprise of standard doses of pembrolizumab and bevacizumab but binimetinib would be at a dose lower of 30 mg PO BID. If 2 or more patients experience a DLT at dose level-1, then patients will be enrolled in dose level -2 which will comprise of standard doses of pembrolizumab and bevacizumab but a lower dose of binimetinib at 15 mg BID. Upon determination of the safety and tolerability of the treatment regimen, the study will proceed to stage 2.
Cohort A
n=21 participants at risk
Patients will start with 7-day run-in of binimetinib on day -7 of cycle 1 only. Pembrolizumab and bevacizumab will then be added to binimetinib on cycle 1 day +1. Cycle 1 will end on day 21. Patients will start treatment with pembrolizumab, binimetinib, and bevacizumab on day 1 of all subsequent cycles.
Cohort B
n=21 participants at risk
Patients will be treated with pembrolizumab, bevacizumab, and binimetinib together on day 1 of all cycles including cycle 1. Patients will start treatment with pembrolizumab, binimetinib, and bevacizumab on day 1 of all subsequent cycles.
Skin and subcutaneous tissue disorders
Bruising
18.2%
2/11 • Number of events 2 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Blood and lymphatic system disorders
CPK Increased
63.6%
7/11 • Number of events 9 • 3 years, 4 months
23.8%
5/21 • Number of events 8 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Blood and lymphatic system disorders
Dehydration
9.1%
1/11 • Number of events 1 • 3 years, 4 months
9.5%
2/21 • Number of events 2 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Skin and subcutaneous tissue disorders
Rash Acneiform
72.7%
8/11 • Number of events 10 • 3 years, 4 months
81.0%
17/21 • Number of events 40 • 3 years, 4 months
71.4%
15/21 • Number of events 19 • 3 years, 4 months
Blood and lymphatic system disorders
Alkaline Phosphatase Increased
18.2%
2/11 • Number of events 2 • 3 years, 4 months
23.8%
5/21 • Number of events 6 • 3 years, 4 months
19.0%
4/21 • Number of events 4 • 3 years, 4 months
Respiratory, thoracic and mediastinal disorders
Cough
36.4%
4/11 • Number of events 4 • 3 years, 4 months
14.3%
3/21 • Number of events 3 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Blood and lymphatic system disorders
Lipase Increased
9.1%
1/11 • Number of events 1 • 3 years, 4 months
9.5%
2/21 • Number of events 2 • 3 years, 4 months
4.8%
1/21 • Number of events 2 • 3 years, 4 months
Skin and subcutaneous tissue disorders
Oral Mucositis
9.1%
1/11 • Number of events 1 • 3 years, 4 months
19.0%
4/21 • Number of events 4 • 3 years, 4 months
9.5%
2/21 • Number of events 3 • 3 years, 4 months
Gastrointestinal disorders
Diarrhea
81.8%
9/11 • Number of events 16 • 3 years, 4 months
47.6%
10/21 • Number of events 15 • 3 years, 4 months
52.4%
11/21 • Number of events 16 • 3 years, 4 months
General disorders
Nausea
72.7%
8/11 • Number of events 9 • 3 years, 4 months
38.1%
8/21 • Number of events 9 • 3 years, 4 months
33.3%
7/21 • Number of events 10 • 3 years, 4 months
Blood and lymphatic system disorders
Alanine Aminotransferase Increase
18.2%
2/11 • Number of events 2 • 3 years, 4 months
19.0%
4/21 • Number of events 7 • 3 years, 4 months
14.3%
3/21 • Number of events 3 • 3 years, 4 months
Blood and lymphatic system disorders
Aspartate Aminotransferase Increase
18.2%
2/11 • Number of events 3 • 3 years, 4 months
28.6%
6/21 • Number of events 13 • 3 years, 4 months
14.3%
3/21 • Number of events 4 • 3 years, 4 months
Blood and lymphatic system disorders
Hypertension
54.5%
6/11 • Number of events 11 • 3 years, 4 months
33.3%
7/21 • Number of events 10 • 3 years, 4 months
19.0%
4/21 • Number of events 4 • 3 years, 4 months
Cardiac disorders
Ejection Fraction Decreased
18.2%
2/11 • Number of events 2 • 3 years, 4 months
14.3%
3/21 • Number of events 5 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
9.1%
1/11 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Blood and lymphatic system disorders
Neutrophil Count Decreased
9.1%
1/11 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 2 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Blood and lymphatic system disorders
Platelet Count Decreased
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Skin and subcutaneous tissue disorders
Edema
18.2%
2/11 • Number of events 2 • 3 years, 4 months
28.6%
6/21 • Number of events 6 • 3 years, 4 months
42.9%
9/21 • Number of events 9 • 3 years, 4 months
General disorders
Abdominal Pain
27.3%
3/11 • Number of events 3 • 3 years, 4 months
38.1%
8/21 • Number of events 9 • 3 years, 4 months
42.9%
9/21 • Number of events 9 • 3 years, 4 months
Eye disorders
Retinopathy
45.5%
5/11 • Number of events 6 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Eye disorders
Blurred Vision
9.1%
1/11 • Number of events 2 • 3 years, 4 months
14.3%
3/21 • Number of events 3 • 3 years, 4 months
14.3%
3/21 • Number of events 3 • 3 years, 4 months
Respiratory, thoracic and mediastinal disorders
Dyspnea
18.2%
2/11 • Number of events 3 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
General disorders
Headache
9.1%
1/11 • Number of events 1 • 3 years, 4 months
9.5%
2/21 • Number of events 2 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
General disorders
Vomiting
36.4%
4/11 • Number of events 5 • 3 years, 4 months
19.0%
4/21 • Number of events 4 • 3 years, 4 months
4.8%
1/21 • Number of events 2 • 3 years, 4 months
Renal and urinary disorders
Proteinuria
27.3%
3/11 • Number of events 4 • 3 years, 4 months
28.6%
6/21 • Number of events 12 • 3 years, 4 months
28.6%
6/21 • Number of events 8 • 3 years, 4 months
Gastrointestinal disorders
Colitis
9.1%
1/11 • Number of events 2 • 3 years, 4 months
9.5%
2/21 • Number of events 3 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Blood and lymphatic system disorders
Hypokalemia
0.00%
0/11 • 3 years, 4 months
9.5%
2/21 • Number of events 3 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Respiratory, thoracic and mediastinal disorders
Lung Infection
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Fatigue
54.5%
6/11 • Number of events 8 • 3 years, 4 months
47.6%
10/21 • Number of events 12 • 3 years, 4 months
71.4%
15/21 • Number of events 18 • 3 years, 4 months
General disorders
Back Pain
36.4%
4/11 • Number of events 4 • 3 years, 4 months
28.6%
6/21 • Number of events 9 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Blood and lymphatic system disorders
Hypophosphatemia
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Renal and urinary disorders
Urinary Tract Infection
18.2%
2/11 • Number of events 2 • 3 years, 4 months
19.0%
4/21 • Number of events 4 • 3 years, 4 months
14.3%
3/21 • Number of events 4 • 3 years, 4 months
Renal and urinary disorders
Hematuria
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Renal and urinary disorders
Urinary Tract obstruction
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Eye disorders
dry eye
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Skin and subcutaneous tissue disorders
Peripheral Sensory Neuropathy
36.4%
4/11 • Number of events 4 • 3 years, 4 months
33.3%
7/21 • Number of events 7 • 3 years, 4 months
19.0%
4/21 • Number of events 5 • 3 years, 4 months
Skin and subcutaneous tissue disorders
Pruritus
9.1%
1/11 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Eye disorders
Floaters
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Fever
9.1%
1/11 • Number of events 1 • 3 years, 4 months
9.5%
2/21 • Number of events 2 • 3 years, 4 months
19.0%
4/21 • Number of events 5 • 3 years, 4 months
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
9.1%
1/11 • Number of events 4 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
9.5%
2/21 • Number of events 3 • 3 years, 4 months
General disorders
Hot Flashes
9.1%
1/11 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Myalgia
9.1%
1/11 • Number of events 1 • 3 years, 4 months
9.5%
2/21 • Number of events 2 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Musculoskeletal and connective tissue disorders
Arthralgia
9.1%
1/11 • Number of events 2 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Skin and subcutaneous tissue disorders
Papulopustular Rash
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
14.3%
3/21 • Number of events 4 • 3 years, 4 months
Blood and lymphatic system disorders
Anemia
18.2%
2/11 • Number of events 3 • 3 years, 4 months
9.5%
2/21 • Number of events 3 • 3 years, 4 months
9.5%
2/21 • Number of events 2 • 3 years, 4 months
Endocrine disorders
Hypothyroidism
0.00%
0/11 • 3 years, 4 months
23.8%
5/21 • Number of events 5 • 3 years, 4 months
23.8%
5/21 • Number of events 5 • 3 years, 4 months
General disorders
Anorexia
9.1%
1/11 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
9.5%
2/21 • Number of events 3 • 3 years, 4 months
Psychiatric disorders
Anxiety
9.1%
1/11 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
General disorders
Malaise
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
General disorders
Confusion
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
General disorders
Dizziness
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 2 • 3 years, 4 months
Musculoskeletal and connective tissue disorders
Dysarthria
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 2 • 3 years, 4 months
General disorders
Chills
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Renal and urinary disorders
Acute Kidney Injury
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Skin and subcutaneous tissue disorders
Anal Ulcer
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Musculoskeletal and connective tissue disorders
Arthritis
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Gastrointestinal disorders
Ascites
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Cardiac disorders
Asystole
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Cardiac disorders
Atrial Fibrillation
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Blood and lymphatic system disorders
Melena
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Gastrointestinal disorders
Bloating
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Metabolism and nutrition disorders
Increased Bilirubin
0.00%
0/11 • 3 years, 4 months
9.5%
2/21 • Number of events 2 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Musculoskeletal and connective tissue disorders
Chest wall pain
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Blood and lymphatic system disorders
Elevated Cholesterol
18.2%
2/11 • Number of events 2 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Gastrointestinal disorders
Constipation
36.4%
4/11 • Number of events 5 • 3 years, 4 months
28.6%
6/21 • Number of events 6 • 3 years, 4 months
23.8%
5/21 • Number of events 6 • 3 years, 4 months
Renal and urinary disorders
Elevated Creatinine
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Dyspepsia
9.1%
1/11 • Number of events 1 • 3 years, 4 months
9.5%
2/21 • Number of events 2 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Ear Pain
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Eye disorders
Eye Disorders
9.1%
1/11 • Number of events 1 • 3 years, 4 months
14.3%
3/21 • Number of events 3 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
General disorders
Flank Pain
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Gastrointestinal disorders
Gastritis
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Gastrointestinal disorders
Gastroesophageal reflux disease
9.1%
1/11 • Number of events 1 • 3 years, 4 months
14.3%
3/21 • Number of events 3 • 3 years, 4 months
9.5%
2/21 • Number of events 2 • 3 years, 4 months
Gastrointestinal disorders
Gastrointestinal disorders
36.4%
4/11 • Number of events 5 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
9.5%
2/21 • Number of events 4 • 3 years, 4 months
General disorders
General Disorders
9.1%
1/11 • Number of events 1 • 3 years, 4 months
14.3%
3/21 • Number of events 13 • 3 years, 4 months
14.3%
3/21 • Number of events 6 • 3 years, 4 months
General disorders
Muscle weakness
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Cardiac disorders
Heart failure
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
General disorders
Hoarseness
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Blood and lymphatic system disorders
Hypercalcemia
0.00%
0/11 • 3 years, 4 months
14.3%
3/21 • Number of events 3 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Endocrine disorders
Hyperthyroidism
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
9.5%
2/21 • Number of events 2 • 3 years, 4 months
Blood and lymphatic system disorders
Hypomagnesemia
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
9.5%
2/21 • Number of events 2 • 3 years, 4 months
Blood and lymphatic system disorders
Hypertriglyceridemia
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Cardiac disorders
Hypotension
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Insomnia
9.1%
1/11 • Number of events 1 • 3 years, 4 months
9.5%
2/21 • Number of events 2 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
General disorders
Intestinal stoma site bleeding
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Blood and lymphatic system disorders
Leukopenia
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
General disorders
Memory Impairment
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Metabolism and nutrition disorders
Decreased appetite
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder
27.3%
3/11 • Number of events 3 • 3 years, 4 months
23.8%
5/21 • Number of events 7 • 3 years, 4 months
19.0%
4/21 • Number of events 4 • 3 years, 4 months
General disorders
Neck pain
9.1%
1/11 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Nervous system disorders
Nervous system disorders
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
9.5%
2/21 • Number of events 2 • 3 years, 4 months
Musculoskeletal and connective tissue disorders
Osteoporosis
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Pain
18.2%
2/11 • Number of events 2 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Gastrointestinal disorders
pancreatitis
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Nervous system disorders
Peripheral motor neuropathy
0.00%
0/11 • 3 years, 4 months
14.3%
3/21 • Number of events 3 • 3 years, 4 months
19.0%
4/21 • Number of events 4 • 3 years, 4 months
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Psychiatric disorders
PTSD
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Gastrointestinal disorders
Rectal anastomotic leak
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
General disorders
Rectal pain
18.2%
2/11 • Number of events 2 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
9.5%
2/21 • Number of events 2 • 3 years, 4 months
Renal and urinary disorders
Renal and urinary disorders
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Reproductive system and breast disorders
Vaginal Bleeding
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Eye disorders
Retinal detachments
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
General disorders
Seizure
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Blood and lymphatic system disorders
Serum amylase increased
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Cardiac disorders
Sinus tachycardia
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Sinusitis
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
9.1%
1/11 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
14.3%
3/21 • Number of events 3 • 3 years, 4 months
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Infections and infestations
Skin infection
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Sore throat
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Stomach Pain
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Blood and lymphatic system disorders
Stroke
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Toothache
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Respiratory, thoracic and mediastinal disorders
Upper Respiratory infection
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Renal and urinary disorders
Dysuria
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Reproductive system and breast disorders
Vaginal dryness
9.1%
1/11 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Reproductive system and breast disorders
Vaginal Inflammation
0.00%
0/11 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
Blood and lymphatic system disorders
Vascular Disorder (clot)
9.1%
1/11 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
General disorders
Vasovagal reaction
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Eye disorders
Watering Eyes
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Metabolism and nutrition disorders
Weight gain
0.00%
0/11 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Metabolism and nutrition disorders
Weight Loss
9.1%
1/11 • Number of events 1 • 3 years, 4 months
14.3%
3/21 • Number of events 3 • 3 years, 4 months
14.3%
3/21 • Number of events 3 • 3 years, 4 months
Psychiatric disorders
Depression
9.1%
1/11 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 1 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Blood and lymphatic system disorders
Hyperlipidemia
0.00%
0/11 • 3 years, 4 months
9.5%
2/21 • Number of events 2 • 3 years, 4 months
0.00%
0/21 • 3 years, 4 months
Skin and subcutaneous tissue disorders
Rash
9.1%
1/11 • Number of events 1 • 3 years, 4 months
4.8%
1/21 • Number of events 2 • 3 years, 4 months
9.5%
2/21 • Number of events 2 • 3 years, 4 months

Additional Information

Dr. Christopher Lieu

University of Colorado

Phone: 303-724-6390

Results disclosure agreements

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