Trial Outcomes & Findings for Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer (NCT NCT03657641)
NCT ID: NCT03657641
Last Updated: 2026-06-16
Results Overview
Number of patients that required a dose modification while on study treatment, due to a Dose limiting toxicity (DLT), during Phase I and Phase II. DLT was evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 and is defined in the study protocol section 6.2.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
73 participants
Primary outcome timeframe
At the end of Course 1 (each course is 21 days)
Results posted on
2026-06-16
Participant Flow
Participant milestones
| Measure |
Phase I, Dose Level 2
Pembrolizumab 200mg + regorafenib 120mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase I, Dose Level 1
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase I, Expansion
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase II
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
3
|
63
|
|
Overall Study
COMPLETED
|
3
|
4
|
3
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Phase I, Dose Level 1
n=4 Participants
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase I, Dose Level 2
n=3 Participants
Pembrolizumab 200mg + regorafenib 120mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase I, Expansion
n=3 Participants
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase II
n=63 Participants
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37 Years
n=20 Participants
|
36 Years
n=20 Participants
|
54 Years
n=40 Participants
|
56 Years
n=6 Participants
|
54 Years
n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
33 Participants
n=6 Participants
|
37 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
30 Participants
n=6 Participants
|
36 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
8 Participants
n=6 Participants
|
8 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
53 Participants
n=6 Participants
|
63 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
11 Participants
n=6 Participants
|
14 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
8 Participants
n=6 Participants
|
9 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
41 Participants
n=6 Participants
|
47 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=20 Participants
|
3 participants
n=20 Participants
|
3 participants
n=40 Participants
|
63 participants
n=6 Participants
|
73 participants
n=7 Participants
|
|
ECOG Performance Status (PS)
0
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
32 Participants
n=6 Participants
|
35 Participants
n=7 Participants
|
|
ECOG Performance Status (PS)
1
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
31 Participants
n=6 Participants
|
38 Participants
n=7 Participants
|
|
Site of Primary Disease at Diagnosis
Appendix
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
|
Site of Primary Disease at Diagnosis
Colon
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
50 Participants
n=6 Participants
|
55 Participants
n=7 Participants
|
|
Site of Primary Disease at Diagnosis
Rectosigmoid
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
|
Site of Primary Disease at Diagnosis
Rectum
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
11 Participants
n=6 Participants
|
16 Participants
n=7 Participants
|
|
Stage of Cancer at Study Entry
III
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
|
Stage of Cancer at Study Entry
IV
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
60 Participants
n=6 Participants
|
70 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: At the end of Course 1 (each course is 21 days)Population: 70 patient were evaluable and were included in the outcome analysis. 3 patients were not evaluable for response as they did not complete at least one full course of treatment (1 course is 21 days).
Number of patients that required a dose modification while on study treatment, due to a Dose limiting toxicity (DLT), during Phase I and Phase II. DLT was evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 and is defined in the study protocol section 6.2.
Outcome measures
| Measure |
Phase I, Dose Level 1
n=3 Participants
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase I, Dose Level 2
n=3 Participants
Pembrolizumab 200mg + regorafenib 120mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase I, Expansion
n=3 Participants
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase II
n=61 Participants
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
|---|---|---|---|---|
|
Number of Patients With Dose Modification Due to Toxicity
|
1 Patients
|
2 Patients
|
0 Patients
|
5 Patients
|
PRIMARY outcome
Timeframe: At first observation of disease progression or death whichever comes first, up to 3 years and 8 months.Population: 70 patient were evaluable and were included in the outcome analysis. 3 patients were not evaluable for response as they did not complete at least one full course of treatment (1 course is 21 days).
PFS will be calculated from the start of treatment (day 1 of cycle 1) to the first observation of disease progression or death whichever comes first, or to the latest follow up. Kaplan Meier curves will be used for PFS plot. Medians of PFS and their 95% CI confidence intervals will be given.
Outcome measures
| Measure |
Phase I, Dose Level 1
n=3 Participants
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase I, Dose Level 2
n=3 Participants
Pembrolizumab 200mg + regorafenib 120mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase I, Expansion
n=3 Participants
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase II
n=61 Participants
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
|---|---|---|---|---|
|
Progression-free Survival (PFS) (Phase II)
|
3.8 months
Interval 3.5 to 18.9
|
3.7 months
Interval 1.5 to 11.2
|
4.4 months
Interval 1.8 to 6.7
|
1.9 months
Interval 1.8 to 2.9
|
PRIMARY outcome
Timeframe: At last date known to be alive, up to 3 years and 8 months.Population: 70 patient were evaluable and were included in the outcome analysis. 3 patients were not evaluable for response as they did not complete at least one full course of treatment (1 course is 21 days).
OS will be calculated from the start of treatment (day 1 or cycle 1) to death from any cause. Kaplan Meier curves will be used to OS plot. Medians and their 95%CI confidence intervals will be given.
Outcome measures
| Measure |
Phase I, Dose Level 1
n=3 Participants
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase I, Dose Level 2
n=3 Participants
Pembrolizumab 200mg + regorafenib 120mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase I, Expansion
n=3 Participants
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase II
n=61 Participants
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
30.0 Months
Interval 5.6 to 30.0
|
7.2 Months
Interval 1.7 to 20.4
|
9.6 Months
Interval 5.3 to 15.0
|
7.9 Months
Interval 4.4 to 14.3
|
Adverse Events
Phase I, Dose Level 1
Serious events: 4 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase I, Dose Level 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase I, Expansion
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase II
Serious events: 26 serious events
Other events: 63 other events
Deaths: 46 deaths
Serious adverse events
| Measure |
Phase I, Dose Level 1
n=4 participants at risk
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase I, Dose Level 2
n=3 participants at risk
Pembrolizumab 200mg + regorafenib 120mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase I, Expansion
n=3 participants at risk
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase II
n=63 participants at risk
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
|---|---|---|---|---|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
66.7%
2/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
3.2%
2/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
3.2%
2/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Skin and subcutaneous tissue disorders
Hand Foot Syndrome
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
7.9%
5/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
50.0%
2/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
1/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
14.3%
9/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
11.1%
7/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Skin and subcutaneous tissue disorders
Flushing
|
25.0%
1/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
General disorders
Fatigue
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
6.3%
4/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
General disorders
Fever
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
Other adverse events
| Measure |
Phase I, Dose Level 1
n=4 participants at risk
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase I, Dose Level 2
n=3 participants at risk
Pembrolizumab 200mg + regorafenib 120mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase I, Expansion
n=3 participants at risk
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
Phase II
n=63 participants at risk
Pembrolizumab 200mg + regorafenib 80mg. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV Regorafenib: Given PO
|
|---|---|---|---|---|
|
General disorders
Chills
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
General disorders
Edema face
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
4.8%
3/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
General disorders
Edema limbs
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
3.2%
2/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
General disorders
Fatigue
|
100.0%
4/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
66.7%
2/3 • At last date known to be alive (up to 3 years and 8 months).
|
76.2%
48/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
General disorders
Fever
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
11.1%
7/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
General disorders
Flu like symptoms
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
3.2%
2/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
General disorders
Pain
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
12.7%
8/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Infections and infestations
Paronychia
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
3.2%
2/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Infections and infestations
Thrush
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
6.3%
4/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Vascular disorders
Hot flashes
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Vascular disorders
Hypertension
|
75.0%
3/4 • At last date known to be alive (up to 3 years and 8 months).
|
66.7%
2/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
31.7%
20/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Social circumstances
White coat syndrome
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Eye disorders
Cataract
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Eye disorders
Watering eyes
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
2/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
30.2%
19/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Anal pain
|
25.0%
1/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Ascites
|
25.0%
1/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
66.7%
2/3 • At last date known to be alive (up to 3 years and 8 months).
|
17.5%
11/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
17.5%
11/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Dry mouth
|
50.0%
2/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
7.9%
5/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
3.2%
2/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Gastrointestinal disorders - other
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
3.2%
2/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Mucositis oral
|
50.0%
2/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
14.3%
9/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • At last date known to be alive (up to 3 years and 8 months).
|
66.7%
2/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
30.2%
19/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
4.8%
3/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
3.2%
2/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
9.5%
6/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
3/4 • At last date known to be alive (up to 3 years and 8 months).
|
66.7%
2/3 • At last date known to be alive (up to 3 years and 8 months).
|
66.7%
2/3 • At last date known to be alive (up to 3 years and 8 months).
|
49.2%
31/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Blood and lymphatic system disorders
INR increased
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
4.8%
3/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
4.8%
3/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
3.2%
2/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
Weight loss
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
3.2%
2/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
Chlorine increased
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
TSH Increased
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
17.5%
11/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
7.9%
5/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
9.5%
6/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
Platelet count decreased
|
50.0%
2/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
25.4%
16/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
White blood cell decreased
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
15.9%
10/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
7.9%
5/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
2/4 • At last date known to be alive (up to 3 years and 8 months).
|
66.7%
2/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
25.4%
16/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
100.0%
3/3 • At last date known to be alive (up to 3 years and 8 months).
|
44.4%
28/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
Aspartate aminotransferase increased
|
75.0%
3/4 • At last date known to be alive (up to 3 years and 8 months).
|
66.7%
2/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
38.1%
24/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
9.5%
6/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
Cholesterol high
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
Lipase increased
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Investigations
Creatinine increased
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
4.8%
3/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • At last date known to be alive (up to 3 years and 8 months).
|
66.7%
2/3 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
22.2%
14/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
44.4%
28/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
3.2%
2/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
14.3%
9/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
6.3%
4/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
4.8%
3/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
15.9%
10/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
19.0%
12/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
2/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
14.3%
9/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
3.2%
2/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
25.0%
1/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
3.2%
2/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
4.8%
3/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
12.7%
8/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
14.3%
9/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
6.3%
4/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
6.3%
4/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
23.8%
15/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
2/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
52.4%
33/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Nervous system disorders
Tremor
|
25.0%
1/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
9.5%
6/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
3.2%
2/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Renal and urinary disorders
Urinary retention
|
25.0%
1/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
12.7%
8/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
14.3%
9/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
7.9%
5/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
25.0%
1/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
20.6%
13/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
11.1%
7/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
1.6%
1/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Skin and subcutaneous tissue disorders
Hand Foot Syndrome
|
75.0%
3/4 • At last date known to be alive (up to 3 years and 8 months).
|
66.7%
2/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
28.6%
18/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
4.8%
3/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
33.3%
1/3 • At last date known to be alive (up to 3 years and 8 months).
|
12.7%
8/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
9.5%
6/63 • At last date known to be alive (up to 3 years and 8 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • At last date known to be alive (up to 3 years and 8 months).
|
66.7%
2/3 • At last date known to be alive (up to 3 years and 8 months).
|
0.00%
0/3 • At last date known to be alive (up to 3 years and 8 months).
|
15.9%
10/63 • At last date known to be alive (up to 3 years and 8 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place