Trial Outcomes & Findings for Capecitabine, Temozolomide, and Bevacizumab for Metastatic or Unresectable Pancreatic Neuroendocrine Tumors (NCT NCT01525082)
NCT ID: NCT01525082
Last Updated: 2024-02-06
Results Overview
Tumor response to treatment with the combination of capecitabine \& temozolomide plus bevacizumab in patients with metastatic or unresectable pancreatic neuroendocrine tumors was assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions. Response is defined as: * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria The outcome is reported as the number of participants who between 3 and 18 months after treatment initiation achieve CR, PR, or clinical response (PR + CR), each a number without dispersion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
18 months
Results posted on
2024-02-06
Participant Flow
Participant milestones
| Measure |
Bevacizumab + Capecitabine + Temozolomide
Cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal. Assessments for treatment effect are after every 3 cycles of treatment.
* Capecitabine: Capecitabine by mouth twice daily on Days 1 to 14
* Temozolomide: Temozolomide by mouth daily on Days 10 to 14
* Bevacizumab: Bevacizumab IV over 30 to 90 minutes on Days 1 \& 15
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Bevacizumab + Capecitabine + Temozolomide
Cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal. Assessments for treatment effect are after every 3 cycles of treatment.
* Capecitabine: Capecitabine by mouth twice daily on Days 1 to 14
* Temozolomide: Temozolomide by mouth daily on Days 10 to 14
* Bevacizumab: Bevacizumab IV over 30 to 90 minutes on Days 1 \& 15
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Capecitabine, Temozolomide, and Bevacizumab for Metastatic or Unresectable Pancreatic Neuroendocrine Tumors
Baseline characteristics by cohort
| Measure |
Bevacizumab + Capecitabine + Temozolomide
n=20 Participants
Cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal.
Capecitabine: Capecitabine by mouth twice daily on Days 1 to 14
Temozolomide: Temozolomide by mouth daily on Days 10 to 14
Bevacizumab: Bevacizumab IV over 30 to 90 minutes on Days 1 \& 15
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Not all participants were evaluable for response to treatment.
Tumor response to treatment with the combination of capecitabine \& temozolomide plus bevacizumab in patients with metastatic or unresectable pancreatic neuroendocrine tumors was assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions. Response is defined as: * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria The outcome is reported as the number of participants who between 3 and 18 months after treatment initiation achieve CR, PR, or clinical response (PR + CR), each a number without dispersion.
Outcome measures
| Measure |
Bevacizumab + Capecitabine + Temozolomide
n=19 Participants
Cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal.
Capecitabine: Capecitabine by mouth twice daily on Days 1 to 14
Temozolomide: Temozolomide by mouth daily on Days 10 to 14
Bevacizumab: Bevacizumab IV over 30 to 90 minutes on Days 1 \& 15
|
Capecitabine
Toxicities attributed to capecitabine
|
Temozolomide
Toxicities attributed to temozolomide
|
|---|---|---|---|
|
Radiographic Response (RR)
Overall response (OR)
|
9 Participants
|
—
|
—
|
|
Radiographic Response (RR)
Complete Response (CR)
|
0 Participants
|
—
|
—
|
|
Radiographic Response (RR)
Partial Response (PR)
|
9 Participants
|
—
|
—
|
|
Radiographic Response (RR)
Stable Disease (SD)
|
9 Participants
|
—
|
—
|
|
Radiographic Response (RR)
Progressive disease (PD)
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 monthsPatients will be monitored for hematologic (blood and lymphatic), gastrointestinal (stomach and gut), renal (kidney), liver (metabolic), neurological, and systemic (constitutional) toxicities (treatment-related adverse events). Toxicity events occurring during treatment will be tabulated for each indicated organ system, and listed separated for serious and non-serious events, with the toxicity attribution indicated. The outcome is reported as the number of events, a number without dispersion.
Outcome measures
| Measure |
Bevacizumab + Capecitabine + Temozolomide
n=20 Participants
Cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal.
Capecitabine: Capecitabine by mouth twice daily on Days 1 to 14
Temozolomide: Temozolomide by mouth daily on Days 10 to 14
Bevacizumab: Bevacizumab IV over 30 to 90 minutes on Days 1 \& 15
|
Capecitabine
n=20 Participants
Toxicities attributed to capecitabine
|
Temozolomide
n=20 Participants
Toxicities attributed to temozolomide
|
|---|---|---|---|
|
Treatment-related Toxicity
Serious blood or lymphatic
|
1 Toxicities (treatment-related events)
|
0 Toxicities (treatment-related events)
|
0 Toxicities (treatment-related events)
|
|
Treatment-related Toxicity
Serious gastrointestinal
|
1 Toxicities (treatment-related events)
|
0 Toxicities (treatment-related events)
|
0 Toxicities (treatment-related events)
|
|
Treatment-related Toxicity
Serious kidney
|
1 Toxicities (treatment-related events)
|
0 Toxicities (treatment-related events)
|
0 Toxicities (treatment-related events)
|
|
Treatment-related Toxicity
Serious nervous system
|
1 Toxicities (treatment-related events)
|
0 Toxicities (treatment-related events)
|
0 Toxicities (treatment-related events)
|
|
Treatment-related Toxicity
Non-serious blood or lymphatic
|
1 Toxicities (treatment-related events)
|
5 Toxicities (treatment-related events)
|
8 Toxicities (treatment-related events)
|
|
Treatment-related Toxicity
Non-serious gastrointestinal
|
34 Toxicities (treatment-related events)
|
119 Toxicities (treatment-related events)
|
77 Toxicities (treatment-related events)
|
|
Treatment-related Toxicity
Non-serious systemic
|
11 Toxicities (treatment-related events)
|
59 Toxicities (treatment-related events)
|
56 Toxicities (treatment-related events)
|
|
Treatment-related Toxicity
Non-serious kidney
|
69 Toxicities (treatment-related events)
|
0 Toxicities (treatment-related events)
|
0 Toxicities (treatment-related events)
|
|
Treatment-related Toxicity
Non-serious metabolism
|
3 Toxicities (treatment-related events)
|
15 Toxicities (treatment-related events)
|
12 Toxicities (treatment-related events)
|
|
Treatment-related Toxicity
Non-serious nervous system
|
12 Toxicities (treatment-related events)
|
16 Toxicities (treatment-related events)
|
12 Toxicities (treatment-related events)
|
SECONDARY outcome
Timeframe: 82 monthsPopulation: Participants lost to follow-up are not included. The data are final. Participants are not being followed for additional data or analysis.
Progression-free survival (PFS) means the length of time that participants survive without disease (tumor) progression, and was assessed using Kaplan-Meier analysis. The outcome is given as the mean in months with standard error of the mean.
Outcome measures
| Measure |
Bevacizumab + Capecitabine + Temozolomide
n=20 Participants
Cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal.
Capecitabine: Capecitabine by mouth twice daily on Days 1 to 14
Temozolomide: Temozolomide by mouth daily on Days 10 to 14
Bevacizumab: Bevacizumab IV over 30 to 90 minutes on Days 1 \& 15
|
Capecitabine
Toxicities attributed to capecitabine
|
Temozolomide
Toxicities attributed to temozolomide
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
25.2 months
Standard Error 3.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 82 moPopulation: The data are final. Participants are not being followed for additional data or analysis.
Time from the date of enrollment to the date of death due to any cause or the last date the patient was known to be alive (censored observation) at the date of data cutoff for the final analysis. The results will be reported as median in months The length of overall survival (OS) of participants was assessed by Kaplan-Meier analysis. The outcome is given as the median in months with full range.
Outcome measures
| Measure |
Bevacizumab + Capecitabine + Temozolomide
n=20 Participants
Cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal.
Capecitabine: Capecitabine by mouth twice daily on Days 1 to 14
Temozolomide: Temozolomide by mouth daily on Days 10 to 14
Bevacizumab: Bevacizumab IV over 30 to 90 minutes on Days 1 \& 15
|
Capecitabine
Toxicities attributed to capecitabine
|
Temozolomide
Toxicities attributed to temozolomide
|
|---|---|---|---|
|
Overall Survival (OS)
|
49.8 months
Interval 2.3 to 81.9
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: For some participants, tissue was not collected, insufficient tissue was collected, or the tissue analysis failed (no result).
O6-alkylguanine DNA alkyltransferase is a protein that in humans is encoded by the gene "O6-methylguanine DNA methyltransferase" (MGMT). Deficiency of the gene product, ie, the protein, is refereed to as "MGMT deficiency," and is thought to be predictive of response to temozolomide and is more often associated with pancreatic NETs. MGMT status in pre-treatment biopsy specimens was to be assessed by immuno-histochemistry (IHC), and associated to best clinical response. The outcome is reported by the the number of patients that were IHC-positive (MGMT detected) or IHC-negative (MGMT not detected), and by best clinical response \[ie, complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)\]. The outcome is reported as a number without dispersion.
Outcome measures
| Measure |
Bevacizumab + Capecitabine + Temozolomide
n=11 Participants
Cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal.
Capecitabine: Capecitabine by mouth twice daily on Days 1 to 14
Temozolomide: Temozolomide by mouth daily on Days 10 to 14
Bevacizumab: Bevacizumab IV over 30 to 90 minutes on Days 1 \& 15
|
Capecitabine
Toxicities attributed to capecitabine
|
Temozolomide
Toxicities attributed to temozolomide
|
|---|---|---|---|
|
O6-methylguanine DNA Methyltransferase (MGMT) Status by Immunohistochemistry (IHC)
IHC-positive and SD
|
2 participants
|
—
|
—
|
|
O6-methylguanine DNA Methyltransferase (MGMT) Status by Immunohistochemistry (IHC)
IHC-positive and CR
|
0 participants
|
—
|
—
|
|
O6-methylguanine DNA Methyltransferase (MGMT) Status by Immunohistochemistry (IHC)
IHC-positive and PR
|
2 participants
|
—
|
—
|
|
O6-methylguanine DNA Methyltransferase (MGMT) Status by Immunohistochemistry (IHC)
IHC-positive and PD
|
1 participants
|
—
|
—
|
|
O6-methylguanine DNA Methyltransferase (MGMT) Status by Immunohistochemistry (IHC)
IHC-negative and CR
|
0 participants
|
—
|
—
|
|
O6-methylguanine DNA Methyltransferase (MGMT) Status by Immunohistochemistry (IHC)
IHC-negative and PR
|
4 participants
|
—
|
—
|
|
O6-methylguanine DNA Methyltransferase (MGMT) Status by Immunohistochemistry (IHC)
IHC-negative and SD
|
2 participants
|
—
|
—
|
|
O6-methylguanine DNA Methyltransferase (MGMT) Status by Immunohistochemistry (IHC)
IHC-negative and PD
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: For some participants, tissue was not collected, insufficient tissue was collected, or the tissue analysis failed (no result).
O6-alkylguanine DNA alkyltransferase is a protein that in humans is encoded by the gene "O6-methylguanine DNA methyltransferase" (MGMT). Deficiency of the gene product, ie, the protein, is refered to as "MGMT deficiency," and is thought to be predictive of response to temozolomide and is more often associated with pancreatic NETs. MGMT status in pre-treatment biopsy specimens was to be assessed by extent of genetic promoter methylation (an analysis of DNA), and correlated to subject survival. MGMT status in pre-treatment biopsy specimens was to be assessed by promoter methylation assessment (PM), and associated to best clinical response. The outcome is reported by the the number of patients that were PM-positive (MGMT detected) or PM-negative (MGMT not detected), and by best clinical response \[ie, complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)\]. The outcome is reported as a number without dispersion.
Outcome measures
| Measure |
Bevacizumab + Capecitabine + Temozolomide
n=11 Participants
Cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal.
Capecitabine: Capecitabine by mouth twice daily on Days 1 to 14
Temozolomide: Temozolomide by mouth daily on Days 10 to 14
Bevacizumab: Bevacizumab IV over 30 to 90 minutes on Days 1 \& 15
|
Capecitabine
Toxicities attributed to capecitabine
|
Temozolomide
Toxicities attributed to temozolomide
|
|---|---|---|---|
|
O6-methylguanine DNA Methyltransferase (MGMT) by Promoter Methylation
PM-positive and CR
|
0 participants
|
—
|
—
|
|
O6-methylguanine DNA Methyltransferase (MGMT) by Promoter Methylation
PM-positive and PR
|
1 participants
|
—
|
—
|
|
O6-methylguanine DNA Methyltransferase (MGMT) by Promoter Methylation
PM-positive and SD
|
0 participants
|
—
|
—
|
|
O6-methylguanine DNA Methyltransferase (MGMT) by Promoter Methylation
PM-positive and PD
|
0 participants
|
—
|
—
|
|
O6-methylguanine DNA Methyltransferase (MGMT) by Promoter Methylation
PM-negative and CR
|
0 participants
|
—
|
—
|
|
O6-methylguanine DNA Methyltransferase (MGMT) by Promoter Methylation
PM-negative and PR
|
4 participants
|
—
|
—
|
|
O6-methylguanine DNA Methyltransferase (MGMT) by Promoter Methylation
PM-negative and SD
|
5 participants
|
—
|
—
|
|
O6-methylguanine DNA Methyltransferase (MGMT) by Promoter Methylation
PM-negative and PD
|
1 participants
|
—
|
—
|
Adverse Events
Bevacizumab + Capecitabine + Temozolomide
Serious events: 20 serious events
Other events: 20 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Bevacizumab + Capecitabine + Temozolomide
n=20 participants at risk
Cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal.
* Capecitabine: Capecitabine by mouth twice daily on Days 1 to 14
* Temozolomide: Temozolomide by mouth daily on Days 10 to 14
* Bevacizumab: Bevacizumab IV over 30 to 90 minutes on Days 1 \& 15
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Number of events 3 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.0%
3/20 • Number of events 4 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
General disorders
Fever
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • Number of events 2 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Investigations
Blood bilirubin increased
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Nervous system disorders
Seizure
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Renal and urinary disorders
Proteinuria
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
Other adverse events
| Measure |
Bevacizumab + Capecitabine + Temozolomide
n=20 participants at risk
Cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal.
* Capecitabine: Capecitabine by mouth twice daily on Days 1 to 14
* Temozolomide: Temozolomide by mouth daily on Days 10 to 14
* Bevacizumab: Bevacizumab IV over 30 to 90 minutes on Days 1 \& 15
|
|---|---|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
5/20 • Number of events 6 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
3/20 • Number of events 6 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
55.0%
11/20 • Number of events 12 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Blood and lymphatic system disorders
Anemia
|
35.0%
7/20 • Number of events 11 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Cardiac disorders
Sinus bradycardia
|
5.0%
1/20 • Number of events 3 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Cardiac disorders
Palpitations
|
15.0%
3/20 • Number of events 5 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Cardiac disorders
Chest pain
|
15.0%
3/20 • Number of events 6 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Ear and labyrinth disorders
Tinnitus
|
15.0%
3/20 • Number of events 3 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Ear and labyrinth disorders
Ear pain
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Eye disorders
Watering eyes
|
10.0%
2/20 • Number of events 2 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Eye disorders
Blurred vision
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Nausea
|
85.0%
17/20 • Number of events 36 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Vomiting
|
45.0%
9/20 • Number of events 19 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Constipation
|
75.0%
15/20 • Number of events 30 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Diarrhea
|
55.0%
11/20 • Number of events 39 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Bloating
|
25.0%
5/20 • Number of events 8 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
40.0%
8/20 • Number of events 18 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.0%
1/20 • Number of events 3 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Mucositis oral
|
25.0%
5/20 • Number of events 9 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Abdominal pain
|
65.0%
13/20 • Number of events 30 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
2/20 • Number of events 4 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
25.0%
5/20 • Number of events 7 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Oral pain
|
20.0%
4/20 • Number of events 6 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
10.0%
2/20 • Number of events 2 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Lip pain
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
10.0%
2/20 • Number of events 4 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Toothache
|
10.0%
2/20 • Number of events 4 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • Number of events 3 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Anal pain
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Periodontal disease
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
5.0%
1/20 • Number of events 2 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Anal ulcer
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
General disorders
Fatigue
|
80.0%
16/20 • Number of events 57 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
General disorders
Pain
|
25.0%
5/20 • Number of events 44 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
General disorders
Edema limbs
|
35.0%
7/20 • Number of events 11 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
General disorders
General disorders and administration site conditions - Other
|
10.0%
2/20 • Number of events 3 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
General disorders
Fever
|
20.0%
4/20 • Number of events 6 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
General disorders
Localized edema
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
General disorders
Non-cardiac chest pain
|
10.0%
2/20 • Number of events 2 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
General disorders
Flu like symptoms
|
10.0%
2/20 • Number of events 4 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
General disorders
Injection site reaction
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Infections and infestations
Upper respiratory infection
|
25.0%
5/20 • Number of events 5 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Infections and infestations
Paronychia
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Infections and infestations
Vaginal infection
|
5.0%
1/20 • Number of events 2 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Infections and infestations
Skin infection
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Infections and infestations
Gum infection
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Infections and infestations
Otitis media
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Infections and infestations
Tooth infection
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Injury, poisoning and procedural complications
Bruising
|
10.0%
2/20 • Number of events 3 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Investigations
Alanine aminotransferase increased
|
65.0%
13/20 • Number of events 37 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Investigations
Aspartate aminotransferase increased
|
60.0%
12/20 • Number of events 34 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Investigations
Platelet count decreased
|
55.0%
11/20 • Number of events 32 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Investigations
Lymphocyte count decreased
|
60.0%
12/20 • Number of events 38 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Investigations
Blood bilirubin increased
|
25.0%
5/20 • Number of events 30 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Investigations
Creatinine increased
|
50.0%
10/20 • Number of events 27 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Investigations
Alkaline phosphatase increased
|
35.0%
7/20 • Number of events 17 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Investigations
White blood cell decreased
|
30.0%
6/20 • Number of events 12 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Investigations
Neutrophil count decreased
|
25.0%
5/20 • Number of events 12 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Investigations
Weight loss
|
10.0%
2/20 • Number of events 3 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Investigations
INR increased
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Investigations
Weight gain
|
20.0%
4/20 • Number of events 6 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Investigations
Lymphocyte count increased
|
10.0%
2/20 • Number of events 2 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
25.0%
5/20 • Number of events 9 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
30.0%
6/20 • Number of events 10 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Metabolism and nutrition disorders
Anorexia
|
35.0%
7/20 • Number of events 9 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
45.0%
9/20 • Number of events 17 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
70.0%
14/20 • Number of events 61 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.0%
3/20 • Number of events 9 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
20.0%
4/20 • Number of events 7 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
65.0%
13/20 • Number of events 30 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
15.0%
3/20 • Number of events 6 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
35.0%
7/20 • Number of events 15 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
45.0%
9/20 • Number of events 17 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
25.0%
5/20 • Number of events 6 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
20.0%
4/20 • Number of events 8 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
10.0%
2/20 • Number of events 2 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.0%
3/20 • Number of events 3 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
1/20 • Number of events 2 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Nervous system disorders
Dizziness
|
25.0%
5/20 • Number of events 7 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
2/20 • Number of events 4 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Nervous system disorders
Headache
|
50.0%
10/20 • Number of events 22 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Nervous system disorders
Concentration impairment
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Nervous system disorders
Dysgeusia
|
15.0%
3/20 • Number of events 6 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Nervous system disorders
Sinus pain
|
15.0%
3/20 • Number of events 8 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Nervous system disorders
Memory impairment
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Nervous system disorders
Dysesthesia
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Nervous system disorders
Paresthesia
|
5.0%
1/20 • Number of events 2 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Nervous system disorders
Presyncope
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Nervous system disorders
Cognitive disturbance
|
5.0%
1/20 • Number of events 2 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Psychiatric disorders
Depression
|
20.0%
4/20 • Number of events 5 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Number of events 3 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Renal and urinary disorders
Proteinuria
|
65.0%
13/20 • Number of events 53 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Renal and urinary disorders
Hematuria
|
45.0%
9/20 • Number of events 20 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Renal and urinary disorders
Urinary frequency
|
5.0%
1/20 • Number of events 3 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Renal and urinary disorders
Urinary tract pain
|
5.0%
1/20 • Number of events 2 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
10.0%
2/20 • Number of events 2 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Reproductive system and breast disorders
Penile pain
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
80.0%
16/20 • Number of events 30 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
2/20 • Number of events 5 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
8/20 • Number of events 10 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
30.0%
6/20 • Number of events 6 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
5/20 • Number of events 11 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
10.0%
2/20 • Number of events 2 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
60.0%
12/20 • Number of events 28 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
35.0%
7/20 • Number of events 8 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.0%
3/20 • Number of events 4 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Vascular disorders
Flushing
|
10.0%
2/20 • Number of events 2 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Vascular disorders
Hypertension
|
75.0%
15/20 • Number of events 69 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Vascular disorders
Superficial thrombophlebitis
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Vascular disorders
Thromboembolic event
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
|
Vascular disorders
Hot flashes
|
5.0%
1/20 • Number of events 1 • 18 months
This study is a single cohort of one combination treatment. Overall adverse events were collected and reported for the single cohort. No attempt will be made to conduct a retrospective analysis attributing adverse events per an analytical plan not defined in the protocol.
|
Additional Information
Shaheen Shagufta, Clinical Assistant Professor
Stanford University
Phone: 650-725-6454
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place