Trial Outcomes & Findings for CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma (NCT NCT04695977)
NCT ID: NCT04695977
Last Updated: 2026-06-15
Results Overview
ORR, defined as the percentage of participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST vl.l) as assessed by Blinded Independent Central Review (BICR)
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
20 participants
Primary outcome timeframe
Up to approximately 39 months
Results posted on
2026-06-15
Participant Flow
Participant milestones
| Measure |
Nivolumab Monotherapy
All participants received nivolumab monotherapy intravenously (IV) according to the treatment schedule.
|
CMP-001 and Nivolumab
All participants received CMP-001 IT and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
Reasons for withdrawal
| Measure |
Nivolumab Monotherapy
All participants received nivolumab monotherapy intravenously (IV) according to the treatment schedule.
|
CMP-001 and Nivolumab
All participants received CMP-001 IT and nivolumab intravenously (IV) according to the treatment schedule.
|
|---|---|---|
|
Overall Study
Sponsor Decision
|
9
|
4
|
|
Overall Study
Death
|
2
|
5
|
Baseline Characteristics
CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma
Baseline characteristics by cohort
| Measure |
Nivolumab Monotherapy
n=11 Participants
All participants received nivolumab monotherapy IV according to the treatment schedule.
|
CMP-001 and Nivolumab
n=9 Participants
All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.3 years
STANDARD_DEVIATION 10.22 • n=20 Participants
|
66.8 years
STANDARD_DEVIATION 7.14 • n=20 Participants
|
69.3 years
STANDARD_DEVIATION 9.04 • n=40 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 39 monthsPopulation: ITT Analysis Set (includes all participants who were randomized)
ORR, defined as the percentage of participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST vl.l) as assessed by Blinded Independent Central Review (BICR)
Outcome measures
| Measure |
Nivolumab Monotherapy
n=11 Participants
All participants received nivolumab monotherapy IV according to the treatment schedule.
|
CMP-001 and Nivolumab
n=9 Participants
All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
|
|---|---|---|
|
Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR)
|
73 Percentage of participants
Interval 39.03 to 93.98
|
44 Percentage of participants
Interval 13.7 to 78.8
|
SECONDARY outcome
Timeframe: Up to approximately 28 months (122 weeks)Population: Safety Analysis Set (all participants who received at least 1 dose of study treatment)
Number of participants with any treatment-emergent adverse event (TEAE), any serious TEAE, and any TEAE leading to discontinuation or death reported.
Outcome measures
| Measure |
Nivolumab Monotherapy
n=11 Participants
All participants received nivolumab monotherapy IV according to the treatment schedule.
|
CMP-001 and Nivolumab
n=9 Participants
All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
|
|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death
Any TEAE
|
11 Participants
|
9 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death
Any Serious TEAE
|
5 Participants
|
2 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death
Any TEAE leading to death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 28 months (122 weeks)Population: Safety Analysis Set (all participants who received at least 1 dose of study treatment)
Number of participants per NCI CTCAE version 5.0 Adverse Event Grade reported: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living; Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care activities of daily living; Grade 4 Life-threatening consequences: urgent intervention indicated; Grade 5 Death related to adverse event.
Outcome measures
| Measure |
Nivolumab Monotherapy
n=11 Participants
All participants received nivolumab monotherapy IV according to the treatment schedule.
|
CMP-001 and Nivolumab
n=9 Participants
All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
|
|---|---|---|
|
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Grade 1 Mild
|
2 Participants
|
0 Participants
|
|
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Grade 2 Moderate
|
1 Participants
|
6 Participants
|
|
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Grade 3 Severe
|
8 Participants
|
3 Participants
|
|
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Grade 4 Life-threatening
|
0 Participants
|
0 Participants
|
|
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Grade 5 Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 39 monthsPopulation: Number of participants analyzed for TTR included only participants in the ITT Analysis Set who had a confirmed best overall response (BOR) of CR or PR by BICR.
TTR, defined as the time from the date of randomization to the first time when criteria are first met for complete response (CR) or partial response (PR), whichever occurred first, per RECIST vl.1 by BICR.
Outcome measures
| Measure |
Nivolumab Monotherapy
n=8 Participants
All participants received nivolumab monotherapy IV according to the treatment schedule.
|
CMP-001 and Nivolumab
n=4 Participants
All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
|
|---|---|---|
|
Time to Response (TTR) by BICR
|
2.14 Months
Interval 1.81 to 25.03
|
2.27 Months
Interval 2.07 to 4.7
|
SECONDARY outcome
Timeframe: Up to approximately 39 monthsPopulation: Number of participants analyzed for TTR included only participants in the ITT Analysis Set who had a confirmed BOR of CR or PR by Investigator.
TTR, defined as the time from the date of randomization to the first time when criteria are first met for CR or PR, whichever occurred first, per RECIST vl.1 by Investigator.
Outcome measures
| Measure |
Nivolumab Monotherapy
n=9 Participants
All participants received nivolumab monotherapy IV according to the treatment schedule.
|
CMP-001 and Nivolumab
n=5 Participants
All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
|
|---|---|---|
|
Time to Response (TTR) by Investigator
|
2.14 Months
Interval 1.81 to 3.48
|
3.45 Months
Interval 2.17 to 3.58
|
SECONDARY outcome
Timeframe: Up to approximately 39 monthsPopulation: Number of participants analyzed for DOR included only participants in the ITT Analysis Set who had a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) by BICR.
DOR, defined as time from the date of first documented response (CR or PR) to the date of documented progressive disease (PD), based on RECIST vl.1 by BICR or death, whichever occurred first.
Outcome measures
| Measure |
Nivolumab Monotherapy
n=8 Participants
All participants received nivolumab monotherapy IV according to the treatment schedule.
|
CMP-001 and Nivolumab
n=4 Participants
All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
|
|---|---|---|
|
Duration of Response (DOR) by BICR
|
NA Months
Median duration of DOR not reached; Insufficient number of participants with events for estimated lower and upper confidence interval
|
NA Months
Interval 10.185 to
Median duration of DOR not reached; Insufficient number of participants with events for estimated upper confidence interval
|
SECONDARY outcome
Timeframe: Up to approximately 39 monthsPopulation: Number of participants analyzed for DOR included only participants in the ITT Analysis Set who had a confirmed BOR of CR or PR by Investigator.
DOR, defined as time from the date of first documented response (CR or PR) to the date of documented progressive disease (PD), based on RECIST vl.1 by Investigator or death, whichever occurred first.
Outcome measures
| Measure |
Nivolumab Monotherapy
n=9 Participants
All participants received nivolumab monotherapy IV according to the treatment schedule.
|
CMP-001 and Nivolumab
n=5 Participants
All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
|
|---|---|---|
|
Duration of Response (DOR) by Investigator
|
NA Months
Interval 4.172 to
Median duration of DOR not reached; Insufficient number of participants with events for estimated upper confidence interval
|
NA Months
Interval 6.702 to
Median duration of DOR not reached; Insufficient number of participants with events for estimated upper confidence interval
|
SECONDARY outcome
Timeframe: Up to approximately 39 monthsPopulation: Number of participants analyzed included only participants in the ITT Analysis Set who had at least one non-injected target lesion, as assessed by Investigator, in the CMP-001 and Nivolumab reporting group, as prespecified by the protocol.
Confirmed ORR, defined as the percentage of participants in the analysis set who had confirmed BOR of CR or PR based on RECIST vl.1 as assessed by Investigator.
Outcome measures
| Measure |
Nivolumab Monotherapy
n=9 Participants
All participants received nivolumab monotherapy IV according to the treatment schedule.
|
CMP-001 and Nivolumab
All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
|
|---|---|---|
|
Confirmed ORR in Non-injected Target Lesions by Investigator
|
56 Percentage of participants
Interval 21.2 to 86.3
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 39 monthsPopulation: ITT Analysis Set (includes all participants who were randomized)
PFS, defined as the time from the date of randomization to date of documented PD based on RECIST vl.1 by BICR or death, whichever occurred first.
Outcome measures
| Measure |
Nivolumab Monotherapy
n=11 Participants
All participants received nivolumab monotherapy IV according to the treatment schedule.
|
CMP-001 and Nivolumab
n=9 Participants
All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
|
|---|---|---|
|
Progression-free Survival (PFS) by BICR
|
NA Months
Interval 2.07 to
Median duration of PFS not reached; Insufficient number of participants with events for estimated upper confidence interval
|
14.85 Months
Interval 1.971 to
Insufficient number of participants with events for estimated upper confidence interval
|
SECONDARY outcome
Timeframe: Up to approximately 39 monthsPopulation: ITT Analysis Set (includes all participants who were randomized)
PFS, defined as the time from the date of randomization to date of documented PD based on RECIST vl.1 by Investigator or death, whichever occurred first.
Outcome measures
| Measure |
Nivolumab Monotherapy
n=11 Participants
All participants received nivolumab monotherapy IV according to the treatment schedule.
|
CMP-001 and Nivolumab
n=9 Participants
All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
|
|---|---|---|
|
Progression-free Survival (PFS) by Investigator
|
NA Months
Interval 2.103 to
Median duration of PFS not reached; Insufficient number of participants with events for estimated upper confidence interval
|
10.25 Months
Interval 1.971 to
Insufficient number of participants with events for estimated upper confidence interval
|
SECONDARY outcome
Timeframe: Up to approximately 40 months (174 weeks)Population: ITT Analysis Set (includes all participants who were randomized)
OS, defined as the time from the date of randomization to the date of death from any cause.
Outcome measures
| Measure |
Nivolumab Monotherapy
n=11 Participants
All participants received nivolumab monotherapy IV according to the treatment schedule.
|
CMP-001 and Nivolumab
n=9 Participants
All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
|
|---|---|---|
|
Overall Survival (OS) by Investigator
|
NA Months
Interval 3.52 to 37.26
Median duration of OS not reached
|
20.04 Months
Interval 13.8 to 39.89
|
Adverse Events
CMP-001 and Nivolumab
Serious events: 2 serious events
Other events: 9 other events
Deaths: 5 deaths
Nivolumab Monotherapy
Serious events: 5 serious events
Other events: 11 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CMP-001 and Nivolumab
n=9 participants at risk
All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
|
Nivolumab Monotherapy
n=11 participants at risk
All participants received nivolumab monotherapy IV according to the treatment schedule.
|
|---|---|---|
|
Endocrine disorders
Hypophysitis
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Infections and infestations
Pseudomonal skin infection
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Infections and infestations
Sepsis
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
Other adverse events
| Measure |
CMP-001 and Nivolumab
n=9 participants at risk
All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
|
Nivolumab Monotherapy
n=11 participants at risk
All participants received nivolumab monotherapy IV according to the treatment schedule.
|
|---|---|---|
|
General disorders
Influenza like illness
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Gastrointestinal disorders
Pancreatitis
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Gastrointestinal disorders
Stomatitis
|
11.1%
1/9 • Number of events 6 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
General disorders
Chills
|
66.7%
6/9 • Number of events 47 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
General disorders
Fatigue
|
44.4%
4/9 • Number of events 9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
45.5%
5/11 • Number of events 8 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
General disorders
Pyrexia
|
33.3%
3/9 • Number of events 6 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
18.2%
2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
General disorders
Face oedema
|
11.1%
1/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
General disorders
Injection site erythema
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
General disorders
Injection site oedema
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
General disorders
Injection site vesicles
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
General disorders
Localised oedema
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
General disorders
Oedema peripheral
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Gastrointestinal disorders
Nausea
|
55.6%
5/9 • Number of events 13 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
18.2%
2/11 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
3/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
18.2%
2/11 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
18.2%
2/11 • Number of events 5 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
27.3%
3/11 • Number of events 8 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
1/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
6/9 • Number of events 7 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
3/9 • Number of events 5 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
18.2%
2/11 • Number of events 6 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Metabolism and nutrition disorders
Dehydration
|
22.2%
2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
22.2%
2/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
22.2%
2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
22.2%
2/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
22.2%
2/9 • Number of events 5 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
27.3%
3/11 • Number of events 4 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
22.2%
2/9 • Number of events 4 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Metabolism and nutrition disorders
Polydipsia
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
36.4%
4/11 • Number of events 6 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
44.4%
4/9 • Number of events 4 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
18.2%
2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
44.4%
4/9 • Number of events 7 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
27.3%
3/11 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Skin and subcutaneous tissue disorders
Achromotrichia acquired
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
27.3%
3/11 • Number of events 4 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Investigations
Blood creatinine increased
|
33.3%
3/9 • Number of events 4 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Investigations
Lipase increased
|
33.3%
3/9 • Number of events 6 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
18.2%
2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Investigations
Weight decreased
|
22.2%
2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
18.2%
2/11 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
11.1%
1/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Investigations
Activated partial thromboplastin time shortened
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Investigations
Amylase increased
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
18.2%
2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Investigations
Blood lactate dehydrogenase increased
|
11.1%
1/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
18.2%
2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Investigations
Blood prolactin abnormal
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Investigations
International normalised ratio increased
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Investigations
Platelet count decreased
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Investigations
White blood cell count increased
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Investigations
Blood pressure increased
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
27.3%
3/11 • Number of events 11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.2%
2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
18.2%
2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.2%
2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.2%
2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
11.1%
1/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Vascular disorders
Hypertension
|
33.3%
3/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
18.2%
2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Vascular disorders
Embolism
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Vascular disorders
Lymphoedema
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Vascular disorders
Hot flush
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
27.3%
3/11 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Infections and infestations
Enterococcal infection
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Infections and infestations
Fungal infection
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Infections and infestations
Skin infection
|
11.1%
1/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Infections and infestations
COVID-19
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
18.2%
2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Nervous system disorders
Dysgeusia
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Nervous system disorders
Paraesthesia
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Nervous system disorders
Restless legs syndrome
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Nervous system disorders
Tremor
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
18.2%
2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Injury, poisoning and procedural complications
Fall
|
22.2%
2/9 • Number of events 4 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Renal and urinary disorders
Acute kidney injury
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Renal and urinary disorders
Chronic kidney disease
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Renal and urinary disorders
Glycosuria
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Renal and urinary disorders
Haematuria
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
18.2%
2/11 • Number of events 6 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Renal and urinary disorders
Pollakiuria
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Renal and urinary disorders
Proteinuria
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Blood and lymphatic system disorders
Anaemia
|
22.2%
2/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
27.3%
3/11 • Number of events 5 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.2%
2/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
18.2%
2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
27.3%
3/11 • Number of events 4 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Cardiac disorders
Sinus bradycardia
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Ear and labyrinth disorders
Vertigo
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
0.00%
0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
27.3%
3/11 • Number of events 4 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
18.2%
2/11 • Number of events 5 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
9.1%
1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc.
Phone: 844-734-6643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the Sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER