Trial Outcomes & Findings for A Study of B-701 in Combination With Pembrolizumab in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma (NCT NCT03123055)
NCT ID: NCT03123055
Last Updated: 2020-03-18
Results Overview
Number of Participants with Dose Limiting Toxicities within a period of 35 days will be analyzed reviewing the aggregate of adverse events (AEs) and serious adverse events (SAEs) by the B-701 program Safety Oversight Committee and will result in a recommended Phase 2 dose. Six subjects at a time are enrolled and observed for 35 days after the initial dose. If 2 or more subjects experience a DLT that dose will be declared intolerable and de-escalation of the dose will occur.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
28 participants
Primary outcome timeframe
1 year
Results posted on
2020-03-18
Participant Flow
Participant milestones
| Measure |
Phase 2
B-701 (vofatamab, 25 mg/kg plus pembrolizumab (200 mg) will be administered by IV infusion on Cycle 1 Day 1 once every 3 weeks.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of B-701 in Combination With Pembrolizumab in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Phase 2
n=28 Participants
B-701 (vofatamab, 25 mg/kg plus pembrolizumab (200 mg) will be administered by IV infusion on Cycle 1 Day 1 once every 3 weeks.
|
|---|---|
|
Age, Continuous
|
61.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearNumber of Participants with Dose Limiting Toxicities within a period of 35 days will be analyzed reviewing the aggregate of adverse events (AEs) and serious adverse events (SAEs) by the B-701 program Safety Oversight Committee and will result in a recommended Phase 2 dose. Six subjects at a time are enrolled and observed for 35 days after the initial dose. If 2 or more subjects experience a DLT that dose will be declared intolerable and de-escalation of the dose will occur.
Outcome measures
| Measure |
B-701 (Vofatamab) Plus Pembrolizumab
n=8 Participants
B-701 (vofatamab) plus pembrolizumab (200 mg) will be administered by IV infusion on Cycle 1 Day 1 once every 3 weeks in a 6+6 dose escalation designed to determine the RP2D of the combination.
|
|---|---|
|
Number of Participants With Dose Limiting Toxicities Within a Period of 35 Days
|
0 Participants
|
PRIMARY outcome
Timeframe: 2.5 yearsEvaluate the safety and tolerability of B-701 (vofatamab) plus pembrolizumab in subjects with UCC as assessed by number of subjects experiencing adverse events (AEs and SAEs), physical examination findings, laboratory test results, and vital signs over time. This outcome is measured by a safety monitoring committee who regularly met and reviewed aggregate trends of reports AEs, lab ranges, physical exams etc. and determined if the drug was safe to continue.
Outcome measures
| Measure |
B-701 (Vofatamab) Plus Pembrolizumab
n=28 Participants
B-701 (vofatamab) plus pembrolizumab (200 mg) will be administered by IV infusion on Cycle 1 Day 1 once every 3 weeks in a 6+6 dose escalation designed to determine the RP2D of the combination.
|
|---|---|
|
Number of Subjects Experiencing Adverse Events (AEs and SAEs)
|
28 Participants
|
PRIMARY outcome
Timeframe: 2 yearsEvaluate the efficacy of B-701 (vofatamab) plus pembrolizumab in subjects with UCC as measured by objective response rate (ORR) by RECIST 1.1. ORR is defined as the percentage of subjects who have baseline measurable disease and who achieve a best response of either complete response (CR) or partial response (PR).
Outcome measures
| Measure |
B-701 (Vofatamab) Plus Pembrolizumab
n=22 Participants
B-701 (vofatamab) plus pembrolizumab (200 mg) will be administered by IV infusion on Cycle 1 Day 1 once every 3 weeks in a 6+6 dose escalation designed to determine the RP2D of the combination.
|
|---|---|
|
Efficacy of B-701 (Vofatamab) Plus Pembrolizumab Measured by ORR
|
9 Participants
|
SECONDARY outcome
Timeframe: 2.5 yearsPopulation: The study was terminated early and this outcome was not analyzed because the data were not collected.
Whole blood (PBMCs), serum, and plasma samples for biomarker analyses will be obtained prior to infusion of B-701 at pre-defined visit days. The effects of B-701 on the downstream signaling of the FGFR3 pathway, tumor sub-type and on the immune surveillance of UCC tumors will be monitored using techniques that include gene expression profiling (such as whole transcriptome RNAseq), sequencing of T-cell receptors, and immunohistochemistry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: The study was terminated early and this outcome was not analyzed because the data were not collected.
Evaluate the efficacy of B-701 (vofatamab) in combination with pembrolizumab in the treatment of subjects with UCC as measured by duration of objective response (DOR), defined as the time from first occurrence of a documented, objective response until the time of relapse or death from any cause (RECIST 1.1).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: The study was terminated early and this outcome was not analyzed because the data were not collected.
Evaluate the efficacy of B-701 in combination with pembrolizumab in the treatment of subjects with UCC as measured by disease control rate (DCR), defined as the percentage of subjects who achieve either complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: The study was terminated early and this outcome was not analyzed because the data were not collected.
Evaluate the efficacy of B-701 (vofatamab) in combination with pembrolizumab in the treatment of subjects with UCC as measured by progression-free survival (PFS), defined as the time from a first study treatment dose to first occurrence of disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2.5 yearsPopulation: The study was terminated early and this outcome was not analyzed because the data were not collected.
Evaluate the efficacy of B-701 (vofatamab) in combination with pembrolizumab in the treatment of subjects with UCC as measured by overall survival (OS), defined as the time from first study drug administration to death from any cause (RECIST 1.1)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: The study was terminated early and this outcome was not analyzed because the data were not collected.
Evaluate the efficacy of B-701 (vofatamab) in combination with pembrolizumab in the treatment of subjects with UCC as measured by the change over time in subject reported quality of life as measured by the European Organization for Research and Treatment Quality of Life Questionnaire (EORTC QLQ-C30).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPK will be analyzed by measuring B-701 C(trough) levels. B-701 C(trough) levels then will be summarized over time throughout the study and will be compared to predicted B-701 C(trough) levels, whose prediction is based on data observed in previous studies with B-701.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsDetermine the immunogenicity of B-701 as measured by anti-B-701 antibody titers at several time points throughout the study.
Outcome measures
Outcome data not reported
Adverse Events
Phase 2
Serious events: 13 serious events
Other events: 28 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Phase 2
n=28 participants at risk
B-701 (vofatamab, 25 mg/kg plus pembrolizumab (200 mg) will be administered by IV infusion on Cycle 1 Day 1 once every 3 weeks.
|
|---|---|
|
General disorders
Pyrexia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
General disorders
Sudden death
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Kidney Infection
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Sepsis
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Tracheobronchitis
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Urosepsis
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Vascular disorders
Embolism
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
Other adverse events
| Measure |
Phase 2
n=28 participants at risk
B-701 (vofatamab, 25 mg/kg plus pembrolizumab (200 mg) will be administered by IV infusion on Cycle 1 Day 1 once every 3 weeks.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute on chronic respiratory failure
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Acute renal insufficiency
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Investigations
ALP increased
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Investigations
ALT increased
|
10.7%
3/28 • Number of events 3 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
7/28 • Number of events 7 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Anemia aggravated
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Appetite lost
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Investigations
AST increased
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Basilar atelectasis
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Bladder infection
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Bladder pain
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Reproductive system and breast disorders
Bloody vaginal discharge
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Reproductive system and breast disorders
Breast nodule
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Reproductive system and breast disorders
Breast pain
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Burning esophagus
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Eye disorders
Burning in eyes
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Cachexia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Eye disorders
Cataracts
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
General disorders
Chills
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Common cold
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Psychiatric disorders
Confusion
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Cardiac disorders
Congestive heart failure
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
4/28 • Number of events 4 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.7%
3/28 • Number of events 3 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Crackles lung
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Cramps in legs
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Investigations
C-reactive protein increased
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Investigations
Creatinine increased
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
21.4%
6/28 • Number of events 6 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Nervous system disorders
Dizziness aggravated
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exacerbated
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
General disorders
Edema limbs
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Investigations
Elevated liver enzymes
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema facial
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
General disorders
Fatigue
|
25.0%
7/28 • Number of events 7 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
General disorders
Fatigue aggravated
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
General disorders
Fever
|
14.3%
4/28 • Number of events 4 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Vascular disorders
Flushing
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Nervous system disorders
Forgetfulness
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
General disorders
General body pain
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
General disorders
General physical health deterioration
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Gonalgia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Nervous system disorders
Headache
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
General disorders
Hunger
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Vascular disorders
Hypertension arterial
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Endocrine disorders
Hyperthyroidism
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Vascular disorders
Hypotension
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Eye disorders
Itching eyes
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Kidney failure
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Kidney infection
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Kidney pain
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Knee arthritis
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Cardiac disorders
Lateral myocardial infarction
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
General disorders
Leg edema
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Loose stools
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Lower abdominal pain
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Lumbar pain
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia of lower extremities
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
10.7%
3/28 • Number of events 3 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Nausea aggravated
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Investigations
NT-proBNP increased
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Nervous system disorders
Ophthalmic migraine
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in foot
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in lumbar spine
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Reproductive system and breast disorders
Pain pelvic
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Painful R arm
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Nervous system disorders
Paresthesia lower limb
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Phlegmon
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Investigations
Platelet count low
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Pneumonia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Investigations
Procalcitonin increased
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash all over
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Renal calculi
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Respiratory tract infection viral
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Nervous system disorders
Restless leg syndrome
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Shoulder blade pain
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin red
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Nervous system disorders
Slurred speech
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Stomach pain
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Streptococcal infection
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
General disorders
Subfebrile
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Swallowing difficult
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Nervous system disorders
Taste changed
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
General disorders
Thirst
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Tongue black
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Nervous system disorders
Tremor of hands
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Investigations
Troponin increased
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Type I diabetes mellitus
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Unilateral leg pain
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Upper abdominal tenderness
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Upper respiratory infection
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Ureterohydronephrosis
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Urinary frequency
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Urinary urgency
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Urination pain
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
2/28 • Number of events 2 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Investigations
WBC increased
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
General disorders
Weakness
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
General disorders
Weakness worsened
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Investigations
Weight loss
|
10.7%
3/28 • Number of events 3 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Weight loss poor
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound
|
3.6%
1/28 • Number of events 1 • Adverse events were collected from the time of consent through 30 days after the last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place