Trial Outcomes & Findings for The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread (NCT NCT03659136)
NCT ID: NCT03659136
Last Updated: 2025-02-24
Results Overview
Progression-free survival (PFS) defined as the time from randomisation until progressive disease (PD) according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) in combination with modified MD Anderson Criteria (for bone lesion assessment), based on blinded independent assessment or death from any cause, whichever occurred earlier. As per RECIST, PD is defined as at least a 20% increase in the sum of diameters of target lesions, unequivocal progression of non-target lesions or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
103 participants
Primary outcome timeframe
From randomisation until the earliest of disease progression, death or the time point of primary PFS analysis, up to 892 days.
Results posted on
2025-02-24
Participant Flow
A multi-centre, double-blind, placebo-controlled, randomised trial which assess the efficacy of of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with Hormon Receptor+ (HR+)/ Human epidermal growth factor receptor 2 (HER2)- advanced or metastatic breast cancer and non-visceral disease.
All patients were screened for eligibility prior to participation in the trial. Patients were screened from 53 investigational sites in 11 countries, to ensure that they (the patients) strictly met all inclusion and none of the exclusion criteria. Screening could occur 1-28 days prior to randomisation to study treatment, patients were not to be randomised if any of the entry criteria were violated. Re-screening was allowed but only once per patient.
Participant milestones
| Measure |
1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane
1000 mg concentrate for solution for infusion of Xentuzumab (BI 836845) (10mg/mL supplied in 20mL vials (200mg/vial)) was administered once weekly as intravenous infusion over 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
Placebo + 10 mg Everolimus + 25 mg Exemestane
Concentrate for solution for infusion of Placebo was administered once weekly as intravenous infusion of 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
51
|
|
Overall Study
Treated
|
50
|
51
|
|
Overall Study
On-treatment at Cut-off Date for Primary Analysis
|
9
|
12
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
52
|
51
|
Reasons for withdrawal
| Measure |
1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane
1000 mg concentrate for solution for infusion of Xentuzumab (BI 836845) (10mg/mL supplied in 20mL vials (200mg/vial)) was administered once weekly as intravenous infusion over 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
Placebo + 10 mg Everolimus + 25 mg Exemestane
Concentrate for solution for infusion of Placebo was administered once weekly as intravenous infusion of 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
|---|---|---|
|
Overall Study
Not treated
|
2
|
0
|
|
Overall Study
Covid-19 related
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
6
|
|
Overall Study
Adverse Event
|
4
|
6
|
|
Overall Study
Progressive disease
|
37
|
31
|
|
Overall Study
Study closure
|
2
|
2
|
|
Overall Study
Sponsor decision/recommendation
|
3
|
2
|
|
Overall Study
Switched to other drug/therapy
|
2
|
2
|
|
Overall Study
Lack of clinical benefit
|
0
|
1
|
Baseline Characteristics
The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread
Baseline characteristics by cohort
| Measure |
1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane
n=52 Participants
1000 mg concentrate for solution for infusion of Xentuzumab (BI 836845) (10mg/mL supplied in 20mL vials (200mg/vial)) was administered once weekly as intravenous infusion over 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
Placebo + 10 mg Everolimus + 25 mg Exemestane
n=51 Participants
Concentrate for solution for infusion of Placebo was administered once weekly as intravenous infusion of 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.9 Years
STANDARD_DEVIATION 11.3 • n=99 Participants
|
60.3 Years
STANDARD_DEVIATION 9.6 • n=107 Participants
|
60.6 Years
STANDARD_DEVIATION 10.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From randomisation until the earliest of disease progression, death or the time point of primary PFS analysis, up to 892 days.Population: Randomised Set (RS): The randomised set included all randomised patients, regardless of whether they received treatment or not.
Progression-free survival (PFS) defined as the time from randomisation until progressive disease (PD) according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) in combination with modified MD Anderson Criteria (for bone lesion assessment), based on blinded independent assessment or death from any cause, whichever occurred earlier. As per RECIST, PD is defined as at least a 20% increase in the sum of diameters of target lesions, unequivocal progression of non-target lesions or the appearance of new lesions.
Outcome measures
| Measure |
1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane
n=52 Participants
1000 mg concentrate for solution for infusion of Xentuzumab (BI 836845) (10mg/mL supplied in 20mL vials (200mg/vial)) was administered once weekly as intravenous infusion over 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
Placebo + 10 mg Everolimus + 25 mg Exemestane
n=51 Participants
Concentrate for solution for infusion of Placebo was administered once weekly as intravenous infusion of 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
12.7 Months
Interval 6.8 to 29.3
|
11.0 Months
Interval 7.7 to 19.5
|
SECONDARY outcome
Timeframe: From randomisation until death from any cause, up to 995 days.Population: Randomised Set (RS): The randomised set included all randomised patients, regardless of whether they received treatment or not.
Overall survival (OS) defined as the time from randomisation until death from any cause. For patients with 'event' as an outcome for OS: OS\[days\] = date of outcome - date of randomisation + 1. For patients with 'censored' as an outcome for OS: OS (censored)\[days\] = date of outcome - date of randomisation + 1.
Outcome measures
| Measure |
1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane
n=52 Participants
1000 mg concentrate for solution for infusion of Xentuzumab (BI 836845) (10mg/mL supplied in 20mL vials (200mg/vial)) was administered once weekly as intravenous infusion over 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
Placebo + 10 mg Everolimus + 25 mg Exemestane
n=51 Participants
Concentrate for solution for infusion of Placebo was administered once weekly as intravenous infusion of 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Interval 22.3 to
Median and upper bound of 95% CI could not be estimated due to insufficient events and data immaturity.
|
NA Months
Interval 22.3 to
Median and upper bound of 95% CI could not be estimated due to insufficient events and data immaturity.
|
SECONDARY outcome
Timeframe: From randomisation until the earliest of progressive disease or death from any cause, up to 892 days.Population: Randomised Set (RS): The randomised set included all randomised patients, regardless of whether they received treatment or not.
Disease control (DC) was defined as a best overall response (BOR) of either complete response (CR), partial response (PR), stable disease (SD) or Non-CR/No-PD. SD and Non-CR/Non-PR must have been observed up until at least week 24 tumor assessment. BOR was defined according to RECIST v1.1 in combination with modified MD Anderson Criteria (for bone lesion assessment) based on all evaluable tumor assessments from randomisation until the earliest of PD, start of subsequent anti-cancer therapy, loss to follow-up, withdrawal of consent or death. To be aligned with the primary endpoint derivation, tumor assessments after two or more consecutively misses assessments were not considered. DC was assessed by independent reviewers.
Outcome measures
| Measure |
1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane
n=52 Participants
1000 mg concentrate for solution for infusion of Xentuzumab (BI 836845) (10mg/mL supplied in 20mL vials (200mg/vial)) was administered once weekly as intravenous infusion over 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
Placebo + 10 mg Everolimus + 25 mg Exemestane
n=51 Participants
Concentrate for solution for infusion of Placebo was administered once weekly as intravenous infusion of 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
|---|---|---|
|
Number of Patients With Disease Control (DC)
|
29 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: From randomisation until the earliest of progressive disease or death from any cause, up to 892 days.Population: Randomised Set (RS): The randomised set included all randomised patients, regardless of whether they received treatment or not. Only participants with disease control are reported.
Duration of disease control (DC), defined as the time from randomisation until the earliest of disease progression (according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) in combination with modified MD Anderson Criteria (for bone lesion assessment) or death from any cause, among patients with DC. Duration of DC was assessed by independent reviewers. The duration of DC was calculated as followed: For patients with disease progression or death: Duration of DC \[days\] = date of outcome - date of randomisation + 1 For patients without disease progression or death: Duration of DC (censored) \[days\] = date of outcome - date of randomisation + 1
Outcome measures
| Measure |
1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane
n=29 Participants
1000 mg concentrate for solution for infusion of Xentuzumab (BI 836845) (10mg/mL supplied in 20mL vials (200mg/vial)) was administered once weekly as intravenous infusion over 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
Placebo + 10 mg Everolimus + 25 mg Exemestane
n=25 Participants
Concentrate for solution for infusion of Placebo was administered once weekly as intravenous infusion of 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
|---|---|---|
|
Duration of Disease Control (DC)
|
14.6 Months
Interval 9.2 to 29.3
|
18.4 Months
Interval 9.2 to
Insufficient events to estimate upper bound of 95% CI for median.
|
SECONDARY outcome
Timeframe: From randomisation until end of treatment, up to 892 days.Population: Randomised Set (RS): The randomised set included all randomised patients, regardless of whether they received treatment or not.
Number of participants with objective response (OR) by independent assessment. OR is defined as a best overall response of complete response (CR) or partial response (PR). Best overall response is defined according to RECIST v1.1 in combination with modified MD Anderson Criteria (for bone lesion assessment) and will consider all tumor assessments from randomisation until the earliest of PD, start of subsequent anti-cancer therapy, loss to follow-up, withdrawal of consent or death. To be aligned with the primary endpoint derivation, tumor assessments after two or more consecutively misses assessments were not considered.
Outcome measures
| Measure |
1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane
n=52 Participants
1000 mg concentrate for solution for infusion of Xentuzumab (BI 836845) (10mg/mL supplied in 20mL vials (200mg/vial)) was administered once weekly as intravenous infusion over 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
Placebo + 10 mg Everolimus + 25 mg Exemestane
n=51 Participants
Concentrate for solution for infusion of Placebo was administered once weekly as intravenous infusion of 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
|---|---|---|
|
Number of Participants With Objective Response (OR)
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From randomisation until the earliest of pain progression, intensification of pain palliation, death or the time point of progression free survival analysis, up to 843 days.Population: Randomised Set (RS): The randomised set included all randomised patients, regardless of whether they received treatment or not.
Time to pain progression or intensification of pain palliation was defined as the time from randomisation until the earliest of: * 2 point increase from baseline in the Brief Pain Inventory - Short Form (BPI-SF), Item 3 (worst pain), without a decrease (of ≥1 point) from baseline analgesics use (via the 8-point Analgesic Quantification Algorithm \[AQA\]), or * 2 point increase from baseline in the AQA, or Death.
Outcome measures
| Measure |
1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane
n=52 Participants
1000 mg concentrate for solution for infusion of Xentuzumab (BI 836845) (10mg/mL supplied in 20mL vials (200mg/vial)) was administered once weekly as intravenous infusion over 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
Placebo + 10 mg Everolimus + 25 mg Exemestane
n=51 Participants
Concentrate for solution for infusion of Placebo was administered once weekly as intravenous infusion of 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
|---|---|---|
|
Time to Pain Progression or Intensification of Pain Palliation
|
5.6 Months
Interval 3.2 to 9.3
|
3.0 Months
Interval 1.9 to
Insufficient events to estimate upper bound of 95% CI for median.
|
Adverse Events
1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane
Serious events: 13 serious events
Other events: 48 other events
Deaths: 6 deaths
Placebo + 10 mg Everolimus + 25 mg Exemestane
Serious events: 18 serious events
Other events: 50 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane
n=50 participants at risk
1000 mg concentrate for solution for infusion of Xentuzumab (BI 836845) (10mg/mL supplied in 20mL vials (200mg/vial)) was administered once weekly as intravenous infusion over 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
Placebo + 10 mg Everolimus + 25 mg Exemestane
n=51 participants at risk
Concentrate for solution for infusion of Placebo was administered once weekly as intravenous infusion of 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Cardiac disorders
Cardiac failure
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Endocrine disorders
Goitre
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
General disorders
Chest pain
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
General disorders
Generalised oedema
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
General disorders
Oedema peripheral
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
General disorders
Pyrexia
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Infections and infestations
Appendicitis
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Infections and infestations
COVID-19
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
3.9%
2/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Infections and infestations
Tongue abscess
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.0%
2/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Psychiatric disorders
Mental status changes
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Renal and urinary disorders
Renal failure
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Surgical and medical procedures
Oophorectomy bilateral
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Vascular disorders
Jugular vein thrombosis
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Hepatobiliary disorders
Liver injury
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
Other adverse events
| Measure |
1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane
n=50 participants at risk
1000 mg concentrate for solution for infusion of Xentuzumab (BI 836845) (10mg/mL supplied in 20mL vials (200mg/vial)) was administered once weekly as intravenous infusion over 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
Placebo + 10 mg Everolimus + 25 mg Exemestane
n=51 participants at risk
Concentrate for solution for infusion of Placebo was administered once weekly as intravenous infusion of 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
10/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
25.5%
13/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.0%
9/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
22.0%
11/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Ear and labyrinth disorders
Ear pain
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
10.0%
5/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
3.9%
2/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Eye disorders
Dry eye
|
10.0%
5/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Eye disorders
Lacrimation increased
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
5/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.0%
7/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
7.8%
4/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
5/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
17.6%
9/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
56.0%
28/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
33.3%
17/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
5/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
15.7%
8/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.0%
4/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Nausea
|
36.0%
18/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
27.5%
14/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Oral pain
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
28.0%
14/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
29.4%
15/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Toothache
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Gastrointestinal disorders
Vomiting
|
18.0%
9/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
15.7%
8/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
General disorders
Asthenia
|
20.0%
10/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
25.5%
13/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
General disorders
Chest pain
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
7.8%
4/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
General disorders
Fatigue
|
44.0%
22/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
33.3%
17/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
General disorders
Influenza like illness
|
10.0%
5/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
General disorders
Mucosal inflammation
|
30.0%
15/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
33.3%
17/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
General disorders
Oedema peripheral
|
8.0%
4/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
17.6%
9/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
General disorders
Pain
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
9.8%
5/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
General disorders
Pyrexia
|
14.0%
7/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
17.6%
9/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Infections and infestations
COVID-19
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
9.8%
5/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Infections and infestations
Cellulitis
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
7.8%
4/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
7.8%
4/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Infections and infestations
Urinary tract infection
|
18.0%
9/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
17.6%
9/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
14.0%
7/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
3.9%
2/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Investigations
Alanine aminotransferase increased
|
16.0%
8/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
13.7%
7/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
5/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
15.7%
8/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Investigations
Blood albumin decreased
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Investigations
Blood calcium decreased
|
8.0%
4/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Investigations
Blood cholesterol increased
|
8.0%
4/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Investigations
Blood creatine phosphokinase increased
|
14.0%
7/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
7.8%
4/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Investigations
Blood creatinine increased
|
10.0%
5/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Investigations
Blood glucose increased
|
8.0%
4/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Investigations
Blood lactate dehydrogenase increased
|
4.0%
2/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
13.7%
7/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Investigations
Blood triglycerides increased
|
8.0%
4/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.0%
6/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
7.8%
4/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Investigations
Glycosylated haemoglobin increased
|
10.0%
5/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Investigations
Lymphocyte count decreased
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
3.9%
2/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Investigations
Neutrophil count decreased
|
8.0%
4/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
11.8%
6/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Investigations
Platelet count decreased
|
18.0%
9/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
9.8%
5/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Investigations
Weight decreased
|
14.0%
7/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
9.8%
5/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Investigations
White blood cell count decreased
|
4.0%
2/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
36.0%
18/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
35.3%
18/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
2/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
12.0%
6/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
3.9%
2/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.0%
10/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
25.5%
13/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
10.0%
5/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
11.8%
6/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
3.9%
2/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.0%
6/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.0%
4/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
9.8%
5/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
32.0%
16/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
33.3%
17/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
17.6%
9/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.0%
4/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
13.7%
7/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
24.0%
12/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
11.8%
6/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
3.9%
2/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.0%
6/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
7.8%
4/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.0%
4/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
7.8%
4/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.0%
7/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
15.7%
8/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Nervous system disorders
Dizziness
|
18.0%
9/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
7.8%
4/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Nervous system disorders
Dysgeusia
|
20.0%
10/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
11.8%
6/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Nervous system disorders
Headache
|
40.0%
20/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
23.5%
12/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Nervous system disorders
Paraesthesia
|
12.0%
6/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
7.8%
4/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Nervous system disorders
Tremor
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Psychiatric disorders
Anxiety
|
4.0%
2/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
9.8%
5/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Psychiatric disorders
Depression
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Psychiatric disorders
Insomnia
|
14.0%
7/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
9.8%
5/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Renal and urinary disorders
Dysuria
|
8.0%
4/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Renal and urinary disorders
Pollakiuria
|
8.0%
4/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
3.9%
2/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Renal and urinary disorders
Proteinuria
|
2.0%
1/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Reproductive system and breast disorders
Pelvic pain
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.0%
13/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
15.7%
8/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.0%
8/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
15.7%
8/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
30.0%
15/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
15.7%
8/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
2.0%
1/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
5/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
3.9%
2/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
0.00%
0/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
5/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
25.5%
13/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
5/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
8.0%
4/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.0%
6/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.0%
6/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
3.9%
2/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
10/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
17.6%
9/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.0%
13/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
17.6%
9/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.0%
3/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
3.9%
2/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Vascular disorders
Hypertension
|
12.0%
6/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
15.7%
8/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
7.8%
4/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/50 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
5.9%
3/51 • [All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not. \[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER