Trial Outcomes & Findings for Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients (NCT NCT04414540)
NCT ID: NCT04414540
Last Updated: 2026-05-08
Results Overview
A complete response is defined as the disappearance of all target lesions, with any affected lymph nodes reduced to less than 10 mm. A partial response occurs when there is at least a 30% reduction in the total size of target lesions compared with baseline. Progressive disease is indicated by at least a 20% increase in lesion size (with a minimum absolute increase of 5 mm) or the appearance of new lesions. Stable disease describes cases where tumor size changes do not meet criteria for partial response or progressive disease.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Up to 2 years after completion of study treatment
Results posted on
2026-05-08
Participant Flow
Participant milestones
| Measure |
Arm 1: Metformin Before Pembrolizumab
Metformin ER 1000mg daily D-14 to D-7. Metformin ER 2000mg daily D-7 to D1. D1 Begin Pembrolizumab 200mg every 3 weeks, while continuing Metformin ER 2000mg daily.
Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumab: Pembrolizumab q 3 weeks
|
Arm 2: Metformin After Pembrolizumab
D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.
Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumab: Pembrolizumab q 3 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Arm 1: Metformin Before Pembrolizumab
Metformin ER 1000mg daily D-14 to D-7. Metformin ER 2000mg daily D-7 to D1. D1 Begin Pembrolizumab 200mg every 3 weeks, while continuing Metformin ER 2000mg daily.
Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumab: Pembrolizumab q 3 weeks
|
Arm 2: Metformin After Pembrolizumab
D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.
Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumab: Pembrolizumab q 3 weeks
|
|---|---|---|
|
Overall Study
Not able to swallow pills
|
1
|
1
|
|
Overall Study
Patient non-compliance
|
0
|
1
|
Baseline Characteristics
Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients
Baseline characteristics by cohort
| Measure |
Arm 1: Metformin Before Pembrolizumab
n=10 Participants
Metformin ER 1000mg daily D-14 to D-7. Metformin ER 2000mg daily D-7 to D1. D1 Begin Pembrolizumab 200mg every 3 weeks, while continuing Metformin ER 2000mg daily.
Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumab: Pembrolizumab q 3 weeks
|
Arm 2: Metformin After Pembrolizumab
n=11 Participants
D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.
Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumab: Pembrolizumab q 3 weeks
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Age, Continuous
|
66.5 years
n=41 Participants
|
64 years
n=40 Participants
|
64 years
n=81 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=41 Participants
|
2 Participants
n=40 Participants
|
5 Participants
n=81 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=41 Participants
|
9 Participants
n=40 Participants
|
16 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=41 Participants
|
11 Participants
n=40 Participants
|
21 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=81 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=41 Participants
|
10 Participants
n=40 Participants
|
20 Participants
n=81 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=41 Participants
|
11 participants
n=40 Participants
|
21 participants
n=81 Participants
|
|
Smoking History (>=10 pack years)
|
3 Participants
n=41 Participants
|
8 Participants
n=40 Participants
|
11 Participants
n=81 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years after completion of study treatmentPopulation: Of the 21 subjects, only 18 were evaluable via RECIST 1.0 and iRECIST.
A complete response is defined as the disappearance of all target lesions, with any affected lymph nodes reduced to less than 10 mm. A partial response occurs when there is at least a 30% reduction in the total size of target lesions compared with baseline. Progressive disease is indicated by at least a 20% increase in lesion size (with a minimum absolute increase of 5 mm) or the appearance of new lesions. Stable disease describes cases where tumor size changes do not meet criteria for partial response or progressive disease.
Outcome measures
| Measure |
Arm 1: Metformin Before Pembrolizumab
n=9 Participants
Metformin ER 1000mg daily D-14 to D-7. Metformin ER 2000mg daily D-7 to D1. D1 Begin Pembrolizumab 200mg every 3 weeks, while continuing Metformin ER 2000mg daily.
Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumab: Pembrolizumab q 3 weeks
|
Arm 2: Metformin After Pembrolizumab
n=9 Participants
D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.
Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumab: Pembrolizumab q 3 weeks
|
|---|---|---|
|
Overall Response Rate by RECIST 1.1 and iRECIST
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 yearsTo observe and record safety of combination in metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) patients receiving the combination of metformin and pembrolizumab. AEs will be graded and recorded according to NCI CTCAE Version 5.0.
Outcome measures
| Measure |
Arm 1: Metformin Before Pembrolizumab
n=10 Participants
Metformin ER 1000mg daily D-14 to D-7. Metformin ER 2000mg daily D-7 to D1. D1 Begin Pembrolizumab 200mg every 3 weeks, while continuing Metformin ER 2000mg daily.
Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumab: Pembrolizumab q 3 weeks
|
Arm 2: Metformin After Pembrolizumab
n=11 Participants
D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.
Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumab: Pembrolizumab q 3 weeks
|
|---|---|---|
|
Number of Patients With Adverse Events Measured by CTCAE v5.0
|
10 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 1 yearTo observe and record progression free survival in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab.
Outcome measures
| Measure |
Arm 1: Metformin Before Pembrolizumab
n=9 Participants
Metformin ER 1000mg daily D-14 to D-7. Metformin ER 2000mg daily D-7 to D1. D1 Begin Pembrolizumab 200mg every 3 weeks, while continuing Metformin ER 2000mg daily.
Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumab: Pembrolizumab q 3 weeks
|
Arm 2: Metformin After Pembrolizumab
n=9 Participants
D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.
Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumab: Pembrolizumab q 3 weeks
|
|---|---|---|
|
Progression Free Survival (PFS)
|
55.6 percentage of participants
Interval 26.6 to 81.2
|
25.0 percentage of participants
Interval 6.3 to 59.9
|
SECONDARY outcome
Timeframe: 1 yearOverall survival was analyzed using the Kaplan-Meier method. The reported 1-year overall survival percentages represent Kaplan-Meier-estimated probabilities of survival at 1 year and do not correspond to the observed proportion of participants alive or deceased due to censoring. Observed all-cause mortality is reported separately as the number of participants who died due to any cause in each arm.
Outcome measures
| Measure |
Arm 1: Metformin Before Pembrolizumab
n=9 Participants
Metformin ER 1000mg daily D-14 to D-7. Metformin ER 2000mg daily D-7 to D1. D1 Begin Pembrolizumab 200mg every 3 weeks, while continuing Metformin ER 2000mg daily.
Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumab: Pembrolizumab q 3 weeks
|
Arm 2: Metformin After Pembrolizumab
n=9 Participants
D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.
Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumab: Pembrolizumab q 3 weeks
|
|---|---|---|
|
Overall Survival (OS)
|
77.8 percentage of patients who are alive
Interval 44.3 to 94.7
|
55.5 percentage of patients who are alive
Interval 26.6 to 81.2
|
Adverse Events
Arm 1: Metformin Before Pembrolizumab
Serious events: 3 serious events
Other events: 10 other events
Deaths: 6 deaths
Arm 2: Metformin After Pembrolizumab
Serious events: 4 serious events
Other events: 11 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Arm 1: Metformin Before Pembrolizumab
n=10 participants at risk
Metformin ER 1000mg daily D-14 to D-7. Metformin ER 2000mg daily D-7 to D1. D1 Begin Pembrolizumab 200mg every 3 weeks, while continuing Metformin ER 2000mg daily.
Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumab: Pembrolizumab q 3 weeks
|
Arm 2: Metformin After Pembrolizumab
n=11 participants at risk
D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.
Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumab: Pembrolizumab q 3 weeks
|
|---|---|---|
|
Infections and infestations
Bone infection
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Cardiac disorders
Cardiac arrest
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
27.3%
3/11 • Number of events 3 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Infections and infestations
Cellulitis
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Psychiatric disorders
Confusion
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
2/10 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Injury, poisoning and procedural complications
Fracture
|
10.0%
1/10 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Hip dislocation
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
20.0%
2/10 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Infections and infestations
Port site infection
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
18.2%
2/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
Other adverse events
| Measure |
Arm 1: Metformin Before Pembrolizumab
n=10 participants at risk
Metformin ER 1000mg daily D-14 to D-7. Metformin ER 2000mg daily D-7 to D1. D1 Begin Pembrolizumab 200mg every 3 weeks, while continuing Metformin ER 2000mg daily.
Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumab: Pembrolizumab q 3 weeks
|
Arm 2: Metformin After Pembrolizumab
n=11 participants at risk
D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks.
Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
Pembrolizumab: Pembrolizumab q 3 weeks
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal cyst
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal nodule
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Abdominal pain
|
30.0%
3/10 • Number of events 4 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Immune system disorders
Allergic reaction
|
10.0%
1/10 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
5/10 • Number of events 7 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
63.6%
7/11 • Number of events 11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Nervous system disorders
Anosmia
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Psychiatric disorders
Anxiety
|
30.0%
3/10 • Number of events 4 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Immune system disorders
Autoimmune Dermatitis
|
10.0%
1/10 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
2/10 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Eye disorders
Blurred vision
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Injury, poisoning and procedural complications
Bruising
|
20.0%
2/10 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Injury, poisoning and procedural complications
Buttock Wound
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
General disorders
Chills
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
27.3%
3/11 • Number of events 4 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Number of events 3 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
45.5%
5/11 • Number of events 7 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 3 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
45.5%
5/11 • Number of events 7 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Infections and infestations
COVID-19
|
30.0%
3/10 • Number of events 3 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Investigations
Creatinine increased
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
36.4%
4/11 • Number of events 4 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
27.3%
3/11 • Number of events 3 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Psychiatric disorders
Depression
|
30.0%
3/10 • Number of events 5 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Diarrhea
|
70.0%
7/10 • Number of events 16 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
54.5%
6/11 • Number of events 13 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Nervous system disorders
Dizziness
|
40.0%
4/10 • Number of events 5 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
27.3%
3/11 • Number of events 3 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
1/10 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
18.2%
2/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Nervous system disorders
Dysgeusia
|
40.0%
4/10 • Number of events 4 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Dysphagia
|
40.0%
4/10 • Number of events 5 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
63.6%
7/11 • Number of events 9 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
45.5%
5/11 • Number of events 6 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Ear and labyrinth disorders
Ear congestion
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Ear and labyrinth disorders
Ear pain
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
18.2%
2/11 • Number of events 3 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
General disorders
Edema face
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
General disorders
Edema limbs
|
20.0%
2/10 • Number of events 3 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Esophageal pain
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Excessive Saliva Production
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • Number of events 3 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
18.2%
2/11 • Number of events 5 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
General disorders
Fatigue
|
80.0%
8/10 • Number of events 16 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
72.7%
8/11 • Number of events 13 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
General disorders
Fever
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
36.4%
4/11 • Number of events 9 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
General disorders
Flu like symptoms
|
10.0%
1/10 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Investigations
Folate Deficiency
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Injury, poisoning and procedural complications
Fracture
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Nervous system disorders
Gait disturbance
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Blood in stool
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
18.2%
2/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 6 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
27.3%
3/11 • Number of events 3 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
18.2%
2/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
General disorders
Hot sensation around ears
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
18.2%
2/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Hyperphagia
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
36.4%
4/11 • Number of events 6 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Investigations
Hypochloremia
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
36.4%
4/11 • Number of events 4 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
18.2%
2/11 • Number of events 3 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
18.2%
2/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
45.5%
5/11 • Number of events 7 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Endocrine disorders
Hypothyroidism
|
30.0%
3/10 • Number of events 3 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
18.2%
2/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Investigations
Increased BUN
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
27.3%
3/11 • Number of events 3 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Investigations
Increased lactate
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
18.2%
2/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
General disorders
Injection site reaction
|
30.0%
3/10 • Number of events 3 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
18.2%
2/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Knee and shoulder ache
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Infections and infestations
Lung infection
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Lung inflammation
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Vascular disorders
Lymphedema
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
General disorders
Malaise
|
30.0%
3/10 • Number of events 4 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
10.0%
1/10 • Number of events 8 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • Number of events 16 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
45.5%
5/11 • Number of events 8 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
General disorders
Neck edema
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
30.0%
3/10 • Number of events 4 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
18.2%
2/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Neck Stiffness
|
20.0%
2/10 • Number of events 3 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
27.3%
3/11 • Number of events 3 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Blood and lymphatic system disorders
Normocytic Anemia
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Odynophagia
|
20.0%
2/10 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
General disorders
Pain
|
60.0%
6/10 • Number of events 11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Pain in shoulder
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Psychiatric disorders
Parasomnia
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Renal and urinary disorders
Polydypsia
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
20.0%
2/10 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
27.3%
3/11 • Number of events 4 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Skin and subcutaneous tissue disorders
Pruritus Rash
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
2/10 • Number of events 3 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
18.2%
2/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cutaneous Squamous cell carcinoma
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sebaceous nodule
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Investigations
Sepsis
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Infections and infestations
Skin infection
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
40.0%
4/10 • Number of events 5 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Stomach pain
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Infections and infestations
Thrush
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
20.0%
2/10 • Number of events 4 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
General disorders
Upper chest burning sensation
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Infections and infestations
Upper respiratory infection
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
18.2%
2/11 • Number of events 3 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Vitamin B12 Deficiency
|
20.0%
2/10 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
20.0%
2/10 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
9.1%
1/11 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Number of events 6 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
54.5%
6/11 • Number of events 10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Investigations
Weight gain
|
30.0%
3/10 • Number of events 5 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Investigations
Weight loss
|
40.0%
4/10 • Number of events 10 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
72.7%
8/11 • Number of events 17 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
10.0%
1/10 • Number of events 1 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
18.2%
2/11 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
|
Injury, poisoning and procedural complications
Wound complication
|
20.0%
2/10 • Number of events 2 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
0.00%
0/11 • All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place