Trial Outcomes & Findings for Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities (NCT NCT04220229)
NCT ID: NCT04220229
Last Updated: 2025-07-17
Results Overview
Cabozantinib treatment begins 8 days prior to initiation of radiation therapy and continues through completion of radiation therapy.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Up to 21 days
Results posted on
2025-07-17
Participant Flow
Study was terminated prior to enrolling participants in Phase II portion of study.
Participant milestones
| Measure |
Treatment (40 mg Cabozantinib S-malate, Radiation Therapy)
Patients receive 40 mg cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
Treatment (60 mg Cabozantinib S-malate, Radiation Therapy)
Patients receive 60 mg cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities
Baseline characteristics by cohort
| Measure |
Phase 1: 40 mg Cabozantinib S-malate, Radiation Therapy
n=3 Participants
Patients receive 40 mg cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy
n=3 Participants
Patients receive 60 mg cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-29
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
30-39
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
40-49
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
50-59
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Customized
60-69
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
70+
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 21 daysCabozantinib treatment begins 8 days prior to initiation of radiation therapy and continues through completion of radiation therapy.
Outcome measures
| Measure |
Treatment (Cabozantinib S-malate, Radiation Therapy)
n=6 Participants
Patients receive cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy
Patients receive 60 mg cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
|---|---|---|
|
Recommended Phase 2 Dose of Cabozantinib S-malate (Cabozantinib) (Phase I)
|
60 mg
|
—
|
PRIMARY outcome
Timeframe: At 12 months after treatment initiationNo patients were enrolled in Phase II portion of study - outcome measure based on Phase I patients.
Outcome measures
| Measure |
Treatment (Cabozantinib S-malate, Radiation Therapy)
n=3 Participants
Patients receive cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy
n=3 Participants
Patients receive 60 mg cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
|---|---|---|
|
Rate of Relapse (Phase II)
|
0 percentage of participants
Interval 0.0 to 71.0
|
33 percentage of participants
Interval 0.0 to 91.0
|
SECONDARY outcome
Timeframe: Up to 1 yearEvaluated utilizing the Exact Clopper-Pearson method.
Outcome measures
| Measure |
Treatment (Cabozantinib S-malate, Radiation Therapy)
n=3 Participants
Patients receive cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy
n=3 Participants
Patients receive 60 mg cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
|---|---|---|
|
Rate of Pathologic Response(>90%)
|
0 percentage of participants
Interval 0.0 to 71.0
|
33 percentage of participants
Interval 0.0 to 91.0
|
SECONDARY outcome
Timeframe: Up to 1 yearEvaluated utilizing the Exact Clopper-Pearson method.
Outcome measures
| Measure |
Treatment (Cabozantinib S-malate, Radiation Therapy)
n=3 Participants
Patients receive cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy
n=3 Participants
Patients receive 60 mg cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
|---|---|---|
|
Rate of Surgical Excision With Negative Margins
|
100 percentage of participants
Interval 29.0 to 100.0
|
100 percentage of participants
Interval 29.0 to 100.0
|
SECONDARY outcome
Timeframe: Up to 1 yearWill be defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Includes those who had complete response and partial response.
Outcome measures
| Measure |
Treatment (Cabozantinib S-malate, Radiation Therapy)
n=3 Participants
Patients receive cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy
n=3 Participants
Patients receive 60 mg cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
|---|---|---|
|
Objective Response Rate
|
0 percentage of participants
Interval 0.0 to 71.0
|
0 percentage of participants
Interval 0.0 to 71.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsEvaluated utilizing the Exact Clopper-Pearson method.
Outcome measures
| Measure |
Treatment (Cabozantinib S-malate, Radiation Therapy)
n=3 Participants
Patients receive cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy
n=3 Participants
Patients receive 60 mg cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
|---|---|---|
|
Rate of Local Relapse
|
0 precentage of participants
Interval 0.0 to 71.0
|
0 precentage of participants
Interval 0.0 to 71.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsEvaluated utilizing the Exact Clopper-Pearson method.
Outcome measures
| Measure |
Treatment (Cabozantinib S-malate, Radiation Therapy)
n=3 Participants
Patients receive cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy
n=3 Participants
Patients receive 60 mg cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
|---|---|---|
|
Rate of Distant Relapse
|
0 percentage of participants
Interval 0.0 to 71.0
|
66 percentage of participants
Interval 9.0 to 99.0
|
SECONDARY outcome
Timeframe: Up to 1 yearEvaluated utilizing the Exact Clopper-Pearson method.
Outcome measures
| Measure |
Treatment (Cabozantinib S-malate, Radiation Therapy)
n=3 Participants
Patients receive cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy
n=3 Participants
Patients receive 60 mg cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
|---|---|---|
|
Relapse-free Survival
|
100 percentage of participants
Interval 29.0 to 100.0
|
66 percentage of participants
Interval 9.0 to 99.0
|
SECONDARY outcome
Timeframe: Up to 1 yearEvaluated utilizing the Exact Clopper-Pearson method.
Outcome measures
| Measure |
Treatment (Cabozantinib S-malate, Radiation Therapy)
n=3 Participants
Patients receive cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy
n=3 Participants
Patients receive 60 mg cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
|---|---|---|
|
Overall Survival
|
100 percentage of participants
Interval 29.0 to 100.0
|
100 percentage of participants
Interval 29.0 to 100.0
|
SECONDARY outcome
Timeframe: Up to 30 days after last dose of investigational product (an average of up to 12 weeks)Adverse events will be graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
Outcome measures
| Measure |
Treatment (Cabozantinib S-malate, Radiation Therapy)
n=3 Participants
Patients receive cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy
n=3 Participants
Patients receive 60 mg cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
|---|---|---|
|
Incidence of Adverse Events - Treatment-related Adverse Events (AEs) Experienced by Participants Evaluated by CTCAE 5.0 and Determined to be Possibly Related, Probably Related, or Definitely Related to Cabozantinib.
Grade 1
|
20 adverse events experienced
|
24 adverse events experienced
|
|
Incidence of Adverse Events - Treatment-related Adverse Events (AEs) Experienced by Participants Evaluated by CTCAE 5.0 and Determined to be Possibly Related, Probably Related, or Definitely Related to Cabozantinib.
Grade 2
|
7 adverse events experienced
|
5 adverse events experienced
|
|
Incidence of Adverse Events - Treatment-related Adverse Events (AEs) Experienced by Participants Evaluated by CTCAE 5.0 and Determined to be Possibly Related, Probably Related, or Definitely Related to Cabozantinib.
Grade 3
|
2 adverse events experienced
|
3 adverse events experienced
|
|
Incidence of Adverse Events - Treatment-related Adverse Events (AEs) Experienced by Participants Evaluated by CTCAE 5.0 and Determined to be Possibly Related, Probably Related, or Definitely Related to Cabozantinib.
Grade 4
|
0 adverse events experienced
|
0 adverse events experienced
|
|
Incidence of Adverse Events - Treatment-related Adverse Events (AEs) Experienced by Participants Evaluated by CTCAE 5.0 and Determined to be Possibly Related, Probably Related, or Definitely Related to Cabozantinib.
Grade 5
|
0 adverse events experienced
|
0 adverse events experienced
|
SECONDARY outcome
Timeframe: Up to 1 yearEvaluated utilizing the Exact Clopper-Pearson method.
Outcome measures
| Measure |
Treatment (Cabozantinib S-malate, Radiation Therapy)
n=3 Participants
Patients receive cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy
n=3 Participants
Patients receive 60 mg cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
|---|---|---|
|
Rate of Treatment Discontinuation Prior to Neoadjuvant Radiation Therapy
|
0 percentage of participants
Interval 0.0 to 71.0
|
0 percentage of participants
Interval 0.0 to 71.0
|
Adverse Events
Phase 1: 40 mg Cabozantinib S-malate, Radiation Therapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase 1: 40 mg Cabozantinib S-malate, Radiation Therapy
n=3 participants at risk
Patients receive 40 mg cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
Phase 1: 60 mg Cabozantinib S-malate, Radiation Therapy
n=3 participants at risk
Patients receive 60 mg cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
Cabozantinib S-malate: Given PO
Radiation Therapy: Undergo standard of care radiation therapy
|
|---|---|---|
|
Gastrointestinal disorders
Mucositis oral
|
100.0%
3/3 • Number of events 3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
100.0%
3/3 • Number of events 3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
100.0%
3/3 • Number of events 4 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
66.7%
2/3 • Number of events 2 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
66.7%
2/3 • Number of events 2 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Gastrointestinal disorders
Bloating
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Eye disorders
Blurred vision
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
3/3 • Number of events 3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
66.7%
2/3 • Number of events 3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 2 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
66.7%
2/3 • Number of events 2 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Nervous system disorders
Dysgeusia
|
66.7%
2/3 • Number of events 3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 2 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
General disorders
Edema face
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 4 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
100.0%
3/3 • Number of events 3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
66.7%
2/3 • Number of events 2 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
General disorders
General disorders and administration site conditions - Other
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Skin and subcutaneous tissue disorders
Hair color changes
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Surgical and medical procedures
Hypertension
|
66.7%
2/3 • Number of events 3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
100.0%
3/3 • Number of events 4 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Nervous system disorders
Memory impairment
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
66.7%
2/3 • Number of events 2 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 2 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Nervous system disorders
Paresthesia
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Eye disorders
Periorbital edema
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
General disorders
Presyncope
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Gastrointestinal disorders
Toothache
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Investigations
Weight loss
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
33.3%
1/3 • Number of events 1 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Number of events 2 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
0.00%
0/3 • Adverse events will be collected up to 30 days post last dose of study treatment, for an average of up to 12 weeks. All-cause mortality was assessed until study end, for an average of 112 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place