Trial Outcomes & Findings for Single Agent Regorafenib in Refractory Advanced Biliary Cancers (NCT NCT02115542)
NCT ID: NCT02115542
Last Updated: 2021-10-12
Results Overview
OS will be defined as the time from starting on trial to date of death due to any cause. The final analysis will be conducted after the follow-time of the last patient exceeds 6 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
at 6 month follow-up
Results posted on
2021-10-12
Participant Flow
Participant milestones
| Measure |
Regorafenib Monotherapy
Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.
Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\<30% fat) breakfast.
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Agent Regorafenib in Refractory Advanced Biliary Cancers
Baseline characteristics by cohort
| Measure |
Regorafenib Monotherapy
n=39 Participants
Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.
Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\<30% fat) breakfast.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 6 month follow-upPopulation: Patients that were evaluable for efficacy
OS will be defined as the time from starting on trial to date of death due to any cause. The final analysis will be conducted after the follow-time of the last patient exceeds 6 months.
Outcome measures
| Measure |
Regorafenib Monotherapy
n=32 Participants
Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.
Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\<30% fat) breakfast.
|
|---|---|
|
Overall Survival (OS) at 6 Months
|
7.9 months
Interval 0.0 to 18.7
|
SECONDARY outcome
Timeframe: Post 6 months follow-up, up to 13 months from on treatment per participantPopulation: Patients that were evaluable for efficacy
DCR defined as Complete Response (CR) + Partial Response (PR)+ Stable Disease (SD). CR: Complete disappearance of all target and non-target lesions (with the exception of lymph nodes mentioned below); No new lesions. PR: Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions; No unequivocal progression of nonmeasurable disease; No new lesions. SD: Does not qualify for CR, PR, Progression or Symptomatic Deterioration.
Outcome measures
| Measure |
Regorafenib Monotherapy
n=32 Participants
Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.
Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\<30% fat) breakfast.
|
|---|---|
|
Disease Control Response (DCR)
|
62.5 percentage of patients
|
SECONDARY outcome
Timeframe: Post 6 months follow-up, up to 13 months from on treatment per participantPFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression - One or more of the following must occur: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site.
Outcome measures
| Measure |
Regorafenib Monotherapy
n=32 Participants
Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.
Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\<30% fat) breakfast.
|
|---|---|
|
Progression Free Survival (PFS)
|
2.8 months
Interval 1.1 to 4.5
|
Adverse Events
Regorafenib Monotherapy
Serious events: 27 serious events
Other events: 39 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Regorafenib Monotherapy
n=39 participants at risk
Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.
Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\<30% fat) breakfast.
|
|---|---|
|
General disorders
Death NOS
|
15.4%
6/39 • Number of events 6 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Gastritis
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Hiccups
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
12.8%
5/39 • Number of events 5 • From consent to study completion, 3 years 3 months
|
|
General disorders
Fatigue
|
10.3%
4/39 • Number of events 4 • From consent to study completion, 3 years 3 months
|
|
Metabolism and nutrition disorders
Dehydration
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Renal and urinary disorders
Acute kidney injury
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Vascular disorders
Thromboembolic event
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders -Other
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
General disorders
Fever
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Nausea
|
7.7%
3/39 • Number of events 3 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
General disorders
Non-cardiac chest pain
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Nervous system disorders
Facial nerve disorder
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Infections and infestations
Infections and Infestations - Other
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
General disorders
Multi-organ failure
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Colitis
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Cardiac disorders
Myocardial infarction
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Infections and infestations
Blood bilirubin increased
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Investigations
Platelet count decreased
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Constipation
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Infections and infestations
Sepsis
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Pancreatitis
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Bile duct stenosis
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
Other adverse events
| Measure |
Regorafenib Monotherapy
n=39 participants at risk
Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.
Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\<30% fat) breakfast.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Abdominal pain
|
51.3%
20/39 • Number of events 34 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Mucositis oral
|
43.6%
17/39 • Number of events 27 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Constipation
|
33.3%
13/39 • Number of events 13 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Nausea
|
30.8%
12/39 • Number of events 20 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
9/39 • Number of events 16 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Ascites
|
20.5%
8/39 • Number of events 8 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
20.5%
8/39 • Number of events 13 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Dry mouth
|
10.3%
4/39 • Number of events 4 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Bloating
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Gastritis
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
5.1%
2/39 • Number of events 3 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Oral pain
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Colitis
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Dyspepsia
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Gastroparesis
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Gingival pain
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Pancreatitis
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Periodontal disease
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Proctitis
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
General disorders
Fatigue
|
64.1%
25/39 • Number of events 42 • From consent to study completion, 3 years 3 months
|
|
General disorders
Fever
|
25.6%
10/39 • Number of events 12 • From consent to study completion, 3 years 3 months
|
|
General disorders
Pain
|
20.5%
8/39 • Number of events 12 • From consent to study completion, 3 years 3 months
|
|
General disorders
Chills
|
10.3%
4/39 • Number of events 6 • From consent to study completion, 3 years 3 months
|
|
General disorders
Non-cardiac chest pain
|
10.3%
4/39 • Number of events 4 • From consent to study completion, 3 years 3 months
|
|
General disorders
Edema limbs
|
7.7%
3/39 • Number of events 3 • From consent to study completion, 3 years 3 months
|
|
General disorders
Flu like symptoms
|
7.7%
3/39 • Number of events 3 • From consent to study completion, 3 years 3 months
|
|
General disorders
General disorders and administration site conditions - other
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
General disorders
Multi-organ faillure
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Investigations
Alkaline phosphatase increased
|
59.0%
23/39 • Number of events 35 • From consent to study completion, 3 years 3 months
|
|
Investigations
Alkaline aminotransferase increased
|
53.8%
21/39 • Number of events 32 • From consent to study completion, 3 years 3 months
|
|
Investigations
Aspartate aminotransferase increased
|
51.3%
20/39 • Number of events 33 • From consent to study completion, 3 years 3 months
|
|
Investigations
Blood bilirubin increased
|
43.6%
17/39 • Number of events 37 • From consent to study completion, 3 years 3 months
|
|
Investigations
Platelet count decreased
|
38.5%
15/39 • Number of events 32 • From consent to study completion, 3 years 3 months
|
|
Investigations
Lymphocyte count decreased
|
35.9%
14/39 • Number of events 31 • From consent to study completion, 3 years 3 months
|
|
Investigations
Weight loss
|
23.1%
9/39 • Number of events 14 • From consent to study completion, 3 years 3 months
|
|
Investigations
White blood cell decreased
|
20.5%
8/39 • Number of events 15 • From consent to study completion, 3 years 3 months
|
|
Investigations
Neutrophil count decreased
|
17.9%
7/39 • Number of events 9 • From consent to study completion, 3 years 3 months
|
|
Investigations
Creatinine increased
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Investigations
Investigations - Other
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Investigations
Lipase increased
|
2.6%
1/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Investigations
Lymphocyte count increased
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
35.9%
14/39 • Number of events 22 • From consent to study completion, 3 years 3 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
13/39 • Number of events 22 • From consent to study completion, 3 years 3 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
30.8%
12/39 • Number of events 12 • From consent to study completion, 3 years 3 months
|
|
Metabolism and nutrition disorders
Anorexia
|
28.2%
11/39 • Number of events 16 • From consent to study completion, 3 years 3 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
23.1%
9/39 • Number of events 14 • From consent to study completion, 3 years 3 months
|
|
Metabolism and nutrition disorders
Dehydration
|
17.9%
7/39 • Number of events 9 • From consent to study completion, 3 years 3 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.4%
6/39 • Number of events 9 • From consent to study completion, 3 years 3 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
15.4%
6/39 • Number of events 7 • From consent to study completion, 3 years 3 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.3%
4/39 • Number of events 6 • From consent to study completion, 3 years 3 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.6%
1/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Vascular disorders
Hypertension
|
56.4%
22/39 • Number of events 48 • From consent to study completion, 3 years 3 months
|
|
Vascular disorders
Flushing
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Vascular disorders
Hypotension
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Vascular disorders
Thromboembolic event
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Vascular disorders
Hot flashes
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
35.9%
14/39 • Number of events 17 • From consent to study completion, 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
6/39 • Number of events 8 • From consent to study completion, 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.8%
5/39 • Number of events 5 • From consent to study completion, 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
1/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Skin and subcutaneous tissue disorders
Pamar-plantar erythrodysesthesia syndrome
|
35.9%
14/39 • Number of events 43 • From consent to study completion, 3 years 3 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.4%
6/39 • Number of events 11 • From consent to study completion, 3 years 3 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
10.3%
4/39 • Number of events 7 • From consent to study completion, 3 years 3 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
3/39 • Number of events 4 • From consent to study completion, 3 years 3 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders -Other
|
5.1%
2/39 • Number of events 4 • From consent to study completion, 3 years 3 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Blood and lymphatic system disorders
Anemia
|
30.8%
12/39 • Number of events 22 • From consent to study completion, 3 years 3 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.1%
2/39 • Number of events 3 • From consent to study completion, 3 years 3 months
|
|
Nervous system disorders
Headache
|
28.2%
11/39 • Number of events 15 • From consent to study completion, 3 years 3 months
|
|
Nervous system disorders
Dizziness
|
10.3%
4/39 • Number of events 5 • From consent to study completion, 3 years 3 months
|
|
Nervous system disorders
Dysgeusia
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Nervous system disorders
Tremor
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Nervous system disorders
Facial nerve disorder
|
2.6%
1/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Nervous system disorders
Radiculitis
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
4/39 • Number of events 5 • From consent to study completion, 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.3%
4/39 • Number of events 4 • From consent to study completion, 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.1%
2/39 • Number of events 4 • From consent to study completion, 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Infections and infestations
Urinary tract infection
|
23.1%
9/39 • Number of events 14 • From consent to study completion, 3 years 3 months
|
|
Infections and infestations
Sepsis
|
7.7%
3/39 • Number of events 3 • From consent to study completion, 3 years 3 months
|
|
Infections and infestations
Infections and infestations - Other
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Infections and infestations
Joint infection
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Infections and infestations
Nail infection
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Infections and infestations
Sinusitis
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Infections and infestations
Skin infection
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Psychiatric disorders
Anxiety
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Psychiatric disorders
Confusion
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Psychiatric disorders
Agitation
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Psychiatric disorders
Depression
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Psychiatric disorders
Hallucinations
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Psychiatric disorders
Insomnia
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Cardiac disorders
Sinus tachycardia
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Cardiac disorders
Myocardial infarction
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Renal and urinary disorders
Cyctitis noninfective
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Renal and urinary disorders
Hematuria
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Renal and urinary disorders
Proteinuria
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Ear and labyrinth disorders
Ear pain
|
5.1%
2/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.6%
1/39 • Number of events 2 • From consent to study completion, 3 years 3 months
|
|
Endocrine disorders
Hypothyroidism
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Eye disorders
Blurred vision
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Eye disorders
Eye disorders - Other
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Hepatobiliary disorders
Bile duct stenosis
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified -Other
|
2.6%
1/39 • Number of events 1 • From consent to study completion, 3 years 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place