Trial Outcomes & Findings for Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury (NCT NCT05507437)
NCT ID: NCT05507437
Last Updated: 2025-12-04
Results Overview
Cmax is defined as the maximum (peak) observed concentration following a dose. TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
Results posted on
2025-12-04
Participant Flow
Participants took part in 7 investigative sites in 5 countries.
The study consisted of a screening period up to 48 hours.
Participant milestones
| Measure |
TIN816
TIN816 2 mg/kg intravenous dose on Day 1.
|
Placebo
Placebo intravenous dose on Day 1
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
4
|
|
Overall Study
COMPLETED
|
12
|
3
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
TIN816
TIN816 2 mg/kg intravenous dose on Day 1.
|
Placebo
Placebo intravenous dose on Day 1
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Death
|
3
|
0
|
Baseline Characteristics
Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury
Baseline characteristics by cohort
| Measure |
TIN816
n=16 Participants
TIN816 2 mg/kg intravenous dose on Day 1.
|
Placebo
n=4 Participants
Placebo intravenous dose on Day 1
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.25 years
STANDARD_DEVIATION 12.250 • n=3 Participants
|
68.0 years
STANDARD_DEVIATION 19.950 • n=3 Participants
|
66.60 years
STANDARD_DEVIATION 13.484 • n=6 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
16 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
14 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
17 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90Population: The pharmacokinetic (PK) analysis set included all participants who survived Day 7 with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received complete study drug regardless of infusion duration.
Cmax is defined as the maximum (peak) observed concentration following a dose. TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Outcome measures
| Measure |
TIN816
n=16 Participants
TIN816 2 mg/kg intravenous dose on Day 1.
|
Placebo
Placebo intravenous dose on Day 1
|
|---|---|---|
|
Maximum Serum Concentration (Cmax) of TIN816
|
40.8 ug/mL
Geometric Coefficient of Variation 36.7
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90Population: The PK analysis set included all participants who survived Day 7 with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received complete study drug regardless of infusion duration.
AUClast is the area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of TIN816. TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Outcome measures
| Measure |
TIN816
n=16 Participants
TIN816 2 mg/kg intravenous dose on Day 1.
|
Placebo
Placebo intravenous dose on Day 1
|
|---|---|---|
|
Area Under Serum Concentration-time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of TIN816
|
99.9 day*ug/mL
Geometric Coefficient of Variation 49.0
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90Population: Patients in the PK analysis set with an available value for the outcome measure. The PK analysis set included all participants who survived Day 7 with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received complete study drug regardless of infusion duration.
The AUC from time zero to infinity (mass x time x volume-1). TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Outcome measures
| Measure |
TIN816
n=13 Participants
TIN816 2 mg/kg intravenous dose on Day 1.
|
Placebo
Placebo intravenous dose on Day 1
|
|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of TIN816
|
104 day*ug/mL
Geometric Coefficient of Variation 47.7
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90Population: The PK analysis set included all participants who survived Day 7 with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received complete study drug regardless of infusion duration.
Tmax is the time to reach maximum (peak) drug concentration after single-dose administration (time). TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Outcome measures
| Measure |
TIN816
n=16 Participants
TIN816 2 mg/kg intravenous dose on Day 1.
|
Placebo
Placebo intravenous dose on Day 1
|
|---|---|---|
|
Time to Reach Maximum Serum Concentration (Tmax) of TIN816
|
0.0868 Day
Interval 0.0597 to 0.163
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90Population: Patients in the PK analysis set with an available value for the outcome measure. The PK analysis set included all participants who survived Day 7 with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received complete study drug regardless of infusion duration.
T1/2 is the elimination half-life associated with the terminal slope. TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Outcome measures
| Measure |
TIN816
n=13 Participants
TIN816 2 mg/kg intravenous dose on Day 1.
|
Placebo
Placebo intravenous dose on Day 1
|
|---|---|---|
|
Terminal Elimination Half-life (T1/2) of TIN816
|
5.70 Day
Geometric Coefficient of Variation 14.8
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90Population: Patients in the PK analysis set with an available value for the outcome measure. The PK analysis set included all participants who survived Day 7 with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received complete study drug regardless of infusion duration.
CL is the total body clearance of TIN816 from the serum following intravenous administration (volume x time-1). TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Outcome measures
| Measure |
TIN816
n=13 Participants
TIN816 2 mg/kg intravenous dose on Day 1.
|
Placebo
Placebo intravenous dose on Day 1
|
|---|---|---|
|
Total Body Clearance (CL) of TIN816
|
0.0189 Liter/day/kg
Geometric Coefficient of Variation 24.7
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90Population: Patients in the PK analysis set with an available value for the outcome measure. The PK analysis set included all participants who survived Day 7 with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received complete study drug regardless of infusion duration.
Vz is the apparent volume of distribution during terminal phase following intravenous administration. TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Outcome measures
| Measure |
TIN816
n=13 Participants
TIN816 2 mg/kg intravenous dose on Day 1.
|
Placebo
Placebo intravenous dose on Day 1
|
|---|---|---|
|
The Apparent Volume of Distribution (Vz) of TIN816
|
0.155 Liter/kg
Geometric Coefficient of Variation 31.7
|
—
|
SECONDARY outcome
Timeframe: Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.Population: The safety analysis set (SAF) included all participants who received one dose of study treatment. Participants were analyzed according to the study treatment received, where treatment received was defined as the participants took at least one dose of that study treatment regardless treatment group randomized to.
Number of participants with treatment emergent AEs (any AE regardless of seriousness) and SAEs.
Outcome measures
| Measure |
TIN816
n=16 Participants
TIN816 2 mg/kg intravenous dose on Day 1.
|
Placebo
n=4 Participants
Placebo intravenous dose on Day 1
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse events
|
14 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious Adverse events
|
11 Participants
|
1 Participants
|
Adverse Events
TIN816
Serious events: 11 serious events
Other events: 14 other events
Deaths: 3 deaths
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
All Patients
Serious events: 12 serious events
Other events: 18 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
TIN816
n=16 participants at risk
TIN816 2 mg/kg intravenous dose on Day 1.
|
Placebo
n=4 participants at risk
Placebo intravenous dose on Day 1
|
All Patients
n=20 participants at risk
All Patients
|
|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
Septic shock
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Cardiac disorders
Atrial fibrillation
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Gastrointestinal disorders
Pancreatitis
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
Infectious pleural effusion
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
Pneumonia
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Nervous system disorders
Cerebral haematoma
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Renal and urinary disorders
Urinary retention
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Vascular disorders
Distributive shock
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
Other adverse events
| Measure |
TIN816
n=16 participants at risk
TIN816 2 mg/kg intravenous dose on Day 1.
|
Placebo
n=4 participants at risk
Placebo intravenous dose on Day 1
|
All Patients
n=20 participants at risk
All Patients
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Gastrointestinal disorders
Constipation
|
18.8%
3/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
15.0%
3/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
50.0%
2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
15.0%
3/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Gastrointestinal disorders
Faecaloma
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Gastrointestinal disorders
Oesophagitis
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
General disorders
Chest pain
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
General disorders
Hyperthermia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
General disorders
Pyrexia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
General disorders
Systemic inflammatory response syndrome
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
Bacteraemia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
Bronchitis
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
COVID-19
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
Endocarditis
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
Herpes simplex reactivation
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
Oral candidiasis
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
Skin bacterial infection
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
Systemic candida
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
Urinary tract candidiasis
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Metabolism and nutrition disorders
Hyperferritinaemia
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
18.8%
3/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
20.0%
4/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
18.8%
3/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
15.0%
3/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
18.8%
3/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
15.0%
3/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
15.0%
3/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
18.8%
3/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
20.0%
4/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Metabolism and nutrition disorders
Malnutrition
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Metabolism and nutrition disorders
Vitamin C deficiency
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Nervous system disorders
Extrapyramidal disorder
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Nervous system disorders
Intensive care unit acquired weakness
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Nervous system disorders
Myoclonus
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Psychiatric disorders
Agitation
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Psychiatric disorders
Confusional state
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Psychiatric disorders
Delirium
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
15.0%
3/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Renal and urinary disorders
Urinary retention
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Vascular disorders
Deep vein thrombosis
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Vascular disorders
Haemodynamic instability
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Vascular disorders
Haemorrhage
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Vascular disorders
Hypotension
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Vascular disorders
Jugular vein thrombosis
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Vascular disorders
Shock haemorrhagic
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Blood and lymphatic system disorders
Anaemia
|
18.8%
3/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
50.0%
2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
25.0%
5/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Cardiac disorders
Atrial fibrillation
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Cardiac disorders
Atrioventricular block first degree
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Cardiac disorders
Stress cardiomyopathy
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
|
Eye disorders
Phlyctenular keratoconjunctivitis
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
0.00%
0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER