Trial Outcomes & Findings for 99mTc-rhAnnexin V-128 Imaging and Cardiotoxicity in Patients With Early Breast Cancer (NCT NCT02677714)
NCT ID: NCT02677714
Last Updated: 2020-12-11
Results Overview
The feasibility of imaging apoptotic activity using 99mTc-rhAnnexin V-128 was assessed in the first 10 patients who enrolled and completed the PoC phase of the study by the data monitoring committee (visual image review and consensus). The three reviewers of the DMC did an independent visual assessment of the images using a 1 to 4 point grading system: each observer reviewed the images of each patient and scored either 1 or 2 (uptake was less than or equal to blood pool), these images were considered normal; 3 was equivocal and four equalled abnormal. Only descriptive analysis performed.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Day 0 (Baseline)
Results posted on
2020-12-11
Participant Flow
The study was conducted at single center in Canada.
Participant milestones
| Measure |
99mTc-rhAnnexin V-128 (Part I / Proof of Concept)
After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
|
99mTc-rhAnnexin V-128 (Part II / Phase II)
After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
2
|
|
Overall Study
COMPLETED
|
10
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
99mTc-rhAnnexin V-128 (Part I / Proof of Concept)
After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
|
99mTc-rhAnnexin V-128 (Part II / Phase II)
After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
99mTc-rhAnnexin V-128 Imaging and Cardiotoxicity in Patients With Early Breast Cancer
Baseline characteristics by cohort
| Measure |
99mTc-rhAnnexin V-128 (Part I / Proof of Concept)
n=12 Participants
After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
|
99mTc-rhAnnexin V-128 (Part II / Phase II)
n=2 Participants
After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.3 Years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
39.0 Years
STANDARD_DEVIATION 0.0 • n=7 Participants
|
52.1 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
11 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (Baseline)Population: Full Analysis Set population (FAS). Only the first 10 participants who enrolled and completed the PoC phase of the study were included in the analysis.
The feasibility of imaging apoptotic activity using 99mTc-rhAnnexin V-128 was assessed in the first 10 patients who enrolled and completed the PoC phase of the study by the data monitoring committee (visual image review and consensus). The three reviewers of the DMC did an independent visual assessment of the images using a 1 to 4 point grading system: each observer reviewed the images of each patient and scored either 1 or 2 (uptake was less than or equal to blood pool), these images were considered normal; 3 was equivocal and four equalled abnormal. Only descriptive analysis performed.
Outcome measures
| Measure |
99mTc-rhAnnexin V-128 (Part I / Proof of Concept)
n=10 Participants
After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
|
99mTc-rhAnnexin V-128 (Part II / Phase II)
After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
|
|---|---|---|
|
Part I / Proof of Concept (PoC): Number of Participants Evaluated for Imaging Feasibility
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: 60 and 120 minutes post injection at: Day 0 (Baseline), Visit 2 (After the 2nd and before the 3rd cycle of doxorubicin), Visit 3 (After the 4th cycle of doxorubicin and within 2 weeks), Visit 4 (12 weeks after the 4th cycle of doxorubicin)Population: Full Analysis Set population (FAS). Only the participants who completed the 4 chemotherapy treatment cycles and underwent all study visits were included in the analysis.
Single-Photon Emission Computed Tomography (SPECT)/Computed Tomography (CT) scans of the thorax were acquired with a dual head SPECT/CT gamma camera with low-energy high-resolution collimators at 1 and 2 hours post-injection at each collection time point and were to be compared to Baseline. Myocardial uptake was measured from regions of interest (ROIs) placed over the myocardium on the SPECT images coregistered with the corresponding CT images for anatomic delineation. Myocardial uptake was expressed either in absolute units (% injected dose/g) or as a standardized uptake value (SUV). Only descriptive analysis performed.
Outcome measures
| Measure |
99mTc-rhAnnexin V-128 (Part I / Proof of Concept)
n=10 Participants
After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
|
99mTc-rhAnnexin V-128 (Part II / Phase II)
n=2 Participants
After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
|
|---|---|---|
|
99mTc-rhAnnexin V-128 Myocardial Uptake
Visit 2 - 120 mins after injection
|
0.0029255 percentage of injected dose/g
Standard Deviation 0.0045063
|
0.0004827 percentage of injected dose/g
Standard Deviation 0.0006826
|
|
99mTc-rhAnnexin V-128 Myocardial Uptake
Visit 3 - 60 mins after injection
|
0.0018097 percentage of injected dose/g
Standard Deviation 0.0011105
|
0.0000512 percentage of injected dose/g
Standard Deviation 0.0000723
|
|
99mTc-rhAnnexin V-128 Myocardial Uptake
Visit 3 - 120 mins after injection
|
0.0016232 percentage of injected dose/g
Standard Deviation 0.0008994
|
0.0002995 percentage of injected dose/g
Standard Deviation 0.0004236
|
|
99mTc-rhAnnexin V-128 Myocardial Uptake
Visit 4 - 60 mins after injection
|
0.0020756 percentage of injected dose/g
Standard Deviation 0.0008986
|
0.0010116 percentage of injected dose/g
Standard Deviation 0.0014306
|
|
99mTc-rhAnnexin V-128 Myocardial Uptake
Visit 4 - 120 mins after injection
|
0.0018475 percentage of injected dose/g
Standard Deviation 0.0005084
|
0.0006692 percentage of injected dose/g
Standard Deviation 0.0009463
|
|
99mTc-rhAnnexin V-128 Myocardial Uptake
Day 0 - 60 mins after injection
|
0.0035617 percentage of injected dose/g
Standard Deviation 0.0051846
|
0.0003306 percentage of injected dose/g
Standard Deviation 0.0004675
|
|
99mTc-rhAnnexin V-128 Myocardial Uptake
Day 0 - 120 mins after injection
|
0.0024177 percentage of injected dose/g
Standard Deviation 0.0036831
|
0.0002125 percentage of injected dose/g
Standard Deviation 0.0003004
|
|
99mTc-rhAnnexin V-128 Myocardial Uptake
Visit 2 - 60 mins after injection
|
0.0043825 percentage of injected dose/g
Standard Deviation 0.0067130
|
0.0008123 percentage of injected dose/g
Standard Deviation 0.0011487
|
SECONDARY outcome
Timeframe: Day 0 (Baseline), Visit 2 (After the 2nd and before the 3rd cycle of doxorubicin), Visit 3 (After the 4th cycle of doxorubicin and within 2 weeks), Visit 4 (12 weeks after the 4th cycle of doxorubicin)Population: Full Analysis Set population (FAS). Only the participants who completed the 4 chemotherapy treatment cycles and underwent all study visits were included in the analysis.
The worsening of LV function was to be assessed by comparing cardiac magnetic resonance imaging (CMRI) left ventricular ejection fraction (LVEF) after the 2nd and the 4th cycle of doxorubicin/cyclophosphamide chemotherapy (AC) treatment and after 12 weeks of the last dose of doxorubicin compared to Baseline. Only descriptive analysis performed.
Outcome measures
| Measure |
99mTc-rhAnnexin V-128 (Part I / Proof of Concept)
n=10 Participants
After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
|
99mTc-rhAnnexin V-128 (Part II / Phase II)
n=2 Participants
After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
|
|---|---|---|
|
Changes in Left Ventricular (LV) Function
Day 0
|
66.8 Percent
Standard Deviation 5.37
|
64.0 Percent
Standard Deviation 2.83
|
|
Changes in Left Ventricular (LV) Function
Visit 2
|
66.3 Percent
Standard Deviation 6.07
|
60.5 Percent
Standard Deviation 0.71
|
|
Changes in Left Ventricular (LV) Function
Visit 3
|
64.0 Percent
Standard Deviation 4.57
|
65.0 Percent
Standard Deviation 1.41
|
|
Changes in Left Ventricular (LV) Function
Visit 4
|
63.6 Percent
Standard Deviation 4.22
|
62.5 Percent
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: Day 0 (Baseline), Visit 2 (After the 2nd and before the 3rd cycle of doxorubicin), Visit 3 (After the 4th cycle of doxorubicin and within 2 weeks), Visit 4 (12 weeks after the 4th cycle of doxorubicin)Population: Full Analysis Set population (FAS). For each parameter, only participants with a value at both baseline and post baseline were included in the analysis.
The differences of LV function after the 2nd and the 4th cycle of doxorubicin/cyclophosphamide chemotherapy (AC) treatment and after 12 weeks of the last dose of doxorubicin compared to Baseline were to be correlated with the changes in cardiotoxicity biomarkers: Troponin and N Terminal pro B-type Natriuretic Peptide (NT-proBNP). Only descriptive analysis performed.
Outcome measures
| Measure |
99mTc-rhAnnexin V-128 (Part I / Proof of Concept)
n=12 Participants
After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
|
99mTc-rhAnnexin V-128 (Part II / Phase II)
n=2 Participants
After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
|
|---|---|---|
|
Changes in the Cardiotoxicity Biomarkers (Troponin and NT-proBNP)
Troponin - Day 0
|
0.015 ng/L
Standard Deviation 0.001
|
0.015 ng/L
Standard Deviation 0.000
|
|
Changes in the Cardiotoxicity Biomarkers (Troponin and NT-proBNP)
Troponin - Visit 2
|
0.019 ng/L
Standard Deviation 0.010
|
0.015 ng/L
Standard Deviation 0.000
|
|
Changes in the Cardiotoxicity Biomarkers (Troponin and NT-proBNP)
Troponin - Visit 3
|
0.025 ng/L
Standard Deviation 0.019
|
0.015 ng/L
Standard Deviation 0.000
|
|
Changes in the Cardiotoxicity Biomarkers (Troponin and NT-proBNP)
Troponin - Visit 4
|
0.060 ng/L
Standard Deviation 0.088
|
0.028 ng/L
Standard Deviation 0.018
|
|
Changes in the Cardiotoxicity Biomarkers (Troponin and NT-proBNP)
NT-proBNP - Day 0
|
49.6 ng/L
Standard Deviation 27.50
|
60.0 ng/L
Standard Deviation 63.64
|
|
Changes in the Cardiotoxicity Biomarkers (Troponin and NT-proBNP)
NT-proBNP - Visit 2
|
271.8 ng/L
Standard Deviation 399.76
|
104.0 ng/L
Standard Deviation 86.27
|
|
Changes in the Cardiotoxicity Biomarkers (Troponin and NT-proBNP)
NT-proBNP - Visit 3
|
123.7 ng/L
Standard Deviation 66.30
|
85.0 ng/L
Standard Deviation 49.50
|
|
Changes in the Cardiotoxicity Biomarkers (Troponin and NT-proBNP)
NT-proBNP - Visit 4
|
123.6 ng/L
Standard Deviation 89.27
|
74.0 ng/L
Standard Deviation 29.70
|
Adverse Events
99mTc-rhAnnexin V-128 (Part I / Proof of Concept)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
99mTc-rhAnnexin V-128 (Part II / Phase II)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
99mTc-rhAnnexin V-128 (Part I / Proof of Concept)
n=12 participants at risk
After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
|
99mTc-rhAnnexin V-128 (Part II / Phase II)
n=2 participants at risk
After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Gastrointestinal disorders
Pyrexia
|
0.00%
0/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
50.0%
1/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Infections and infestations
Carbuncle
|
0.00%
0/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
50.0%
1/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
50.0%
1/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Infections and infestations
Escherichia urinary tract infection
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
50.0%
1/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
50.0%
1/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Psychiatric disorders
Delirium
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Renal and urinary disorders
Acute kidney injury
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
Other adverse events
| Measure |
99mTc-rhAnnexin V-128 (Part I / Proof of Concept)
n=12 participants at risk
After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
|
99mTc-rhAnnexin V-128 (Part II / Phase II)
n=2 participants at risk
After reconstitution and radiolabeling, 99mTc-rhAnnexin V-128 was administered as a single intravenous bolus of 350 MBq +/- 10% at baseline, after the 2nd cycle, after the 4th cycle and 12 weeks after AC chemotherapy.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Ear and labyrinth disorders
Hypoacusis
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Eye disorders
Vision blurred
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
50.0%
1/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Gastrointestinal disorders
Duodenogastric reflux
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Gastrointestinal disorders
Dysgeusia
|
0.00%
0/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
50.0%
1/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
50.0%
1/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Gastrointestinal disorders
Nausea
|
33.3%
4/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
100.0%
2/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
50.0%
1/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
General disorders
Chest pain
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
General disorders
Fatigue
|
58.3%
7/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
100.0%
2/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
General disorders
Febrile neutropenia
|
0.00%
0/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
50.0%
1/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Infections and infestations
Oral candidiasis
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Infections and infestations
Respiratory tract infection
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Metabolism and nutrition disorders
Fluid retention
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
2/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
50.0%
6/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
50.0%
1/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Nervous system disorders
Insomnia
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Nervous system disorders
Neuropathy peripheral
|
25.0%
3/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
50.0%
1/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Nervous system disorders
Paraesthesia
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
50.0%
1/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Psychiatric disorders
Sleep disorder due to general medical condition, insomnia type
|
0.00%
0/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
50.0%
1/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Skin and subcutaneous tissue disorders
Herpes zoster
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
3/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin candida
|
8.3%
1/12 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
0.00%
0/2 • From the signing of the informed consent until the last study-related procedure (up to 12 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER