Trial Outcomes & Findings for Safety of DS-1040b in Acute Ischemic Stroke Patients Treated With Thrombectomy (NCT NCT03198715)
NCT ID: NCT03198715
Last Updated: 2021-01-28
Results Overview
Symptomatic and asymptomatic intracranial hemorrhage (ICH) confirmed by head imaging (CT or MRI) are reported. Symptomatic ICH was defined as Intracranial hemorrhage with clinical deterioration causing an increase in the National Institutes of Health Stroke Scale (NIHSS) score of ≥ 4 points (defined by European Cooperative Acute Stroke Study). Asymptomatic ICH included the following: Hemorrhagic infarction type 1: Small petechial hemorrhage along the margins of the infarct, Hemorrhagic infarction type 2: Confluent petechial hemorrhage within the infarcted area, but without a mass effect, Parenchymal hematoma type 1: Hematoma involving ≤ 30% of the infarcted area with a slight mass effect, Parenchymal hematoma type 2: Hematoma involving \> 30% of, or outside the infarcted area, with a significant mass effect.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
From start of treatment up to 36 hours post single, intravenous dose
Results posted on
2021-01-28
Participant Flow
A total of 42 participants who met all inclusion criteria and no exclusion criteria were randomized to treatment. Of the 42 participants randomized, 41 participants received treatment.
The study consisted of 4 parallel, ascending-dose cohorts. The DS-1040b 0.6 mg cohort only consisted of a DS-1040b group. A ratio of DS-1040b:placebo of 3:1 per cohort was used for the 1.2 mg and higher dose cohorts.
Participant milestones
| Measure |
DS-1040b 0.6 mg
Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
|
DS-1040b 1.2 mg
Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
|
DS-1040b 2.4 mg
Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
|
DS-1040b 4.8 mg
Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
|
Placebo
Participants who received a single, intravenous infusion of placebo.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
12
|
12
|
3
|
9
|
|
Overall Study
COMPLETED
|
6
|
11
|
10
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
0
|
2
|
Reasons for withdrawal
| Measure |
DS-1040b 0.6 mg
Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
|
DS-1040b 1.2 mg
Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
|
DS-1040b 2.4 mg
Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
|
DS-1040b 4.8 mg
Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
|
Placebo
Participants who received a single, intravenous infusion of placebo.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
2
|
|
Overall Study
Other
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Safety of DS-1040b in Acute Ischemic Stroke Patients Treated With Thrombectomy
Baseline characteristics by cohort
| Measure |
DS-1040b 0.6 mg
n=6 Participants
Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
|
DS-1040b 1.2 mg
n=12 Participants
Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
|
DS-1040b 2.4 mg
n=11 Participants
Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
|
DS-1040b 4.8 mg
n=3 Participants
Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
|
Placebo
n=9 Participants
Participants who received a single, intravenous infusion of placebo.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
35 Participants
n=30 Participants
|
|
Age, Continuous
|
71.5 years
STANDARD_DEVIATION 6.80 • n=99 Participants
|
76.3 years
STANDARD_DEVIATION 6.96 • n=107 Participants
|
73.6 years
STANDARD_DEVIATION 10.40 • n=206 Participants
|
69.0 years
STANDARD_DEVIATION 7.81 • n=7 Participants
|
76.9 years
STANDARD_DEVIATION 11.22 • n=31 Participants
|
74.5 years
STANDARD_DEVIATION 8.97 • n=30 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
19 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
22 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
41 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
41 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
Japan
|
6 participants
n=99 Participants
|
12 participants
n=107 Participants
|
11 participants
n=206 Participants
|
3 participants
n=7 Participants
|
9 participants
n=31 Participants
|
41 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: From start of treatment up to 36 hours post single, intravenous dosePopulation: Bleeding events were assessed in the Safety Analysis Set.
Symptomatic and asymptomatic intracranial hemorrhage (ICH) confirmed by head imaging (CT or MRI) are reported. Symptomatic ICH was defined as Intracranial hemorrhage with clinical deterioration causing an increase in the National Institutes of Health Stroke Scale (NIHSS) score of ≥ 4 points (defined by European Cooperative Acute Stroke Study). Asymptomatic ICH included the following: Hemorrhagic infarction type 1: Small petechial hemorrhage along the margins of the infarct, Hemorrhagic infarction type 2: Confluent petechial hemorrhage within the infarcted area, but without a mass effect, Parenchymal hematoma type 1: Hematoma involving ≤ 30% of the infarcted area with a slight mass effect, Parenchymal hematoma type 2: Hematoma involving \> 30% of, or outside the infarcted area, with a significant mass effect.
Outcome measures
| Measure |
DS-1040b 0.6 mg
n=6 Participants
Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
|
DS-1040b 1.2 mg
n=12 Participants
Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
|
DS-1040b 2.4 mg
n=11 Participants
Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
|
DS-1040b 4.8 mg
n=3 Participants
Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
|
Placebo
n=9 Participants
Participants who received a single, intravenous infusion of placebo.
|
|---|---|---|---|---|---|
|
Number of Participants With Symptomatic or Asymptomatic Intracranial Hemorrhage (ICH) Within 36 Hours From Start of Treatment With DS-1040b in Acute Ischemic Stroke Participants
Symptomatic ICH
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic or Asymptomatic Intracranial Hemorrhage (ICH) Within 36 Hours From Start of Treatment With DS-1040b in Acute Ischemic Stroke Participants
Asymptomatic ICH
|
2 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Symptomatic or Asymptomatic Intracranial Hemorrhage (ICH) Within 36 Hours From Start of Treatment With DS-1040b in Acute Ischemic Stroke Participants
Hemorrhagic infarction type 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic or Asymptomatic Intracranial Hemorrhage (ICH) Within 36 Hours From Start of Treatment With DS-1040b in Acute Ischemic Stroke Participants
Hemorrhagic infarction type 2
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic or Asymptomatic Intracranial Hemorrhage (ICH) Within 36 Hours From Start of Treatment With DS-1040b in Acute Ischemic Stroke Participants
Parenchymal hematoma type 1
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic or Asymptomatic Intracranial Hemorrhage (ICH) Within 36 Hours From Start of Treatment With DS-1040b in Acute Ischemic Stroke Participants
Parenchymal hematoma type 2
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic or Asymptomatic Intracranial Hemorrhage (ICH) Within 36 Hours From Start of Treatment With DS-1040b in Acute Ischemic Stroke Participants
Not applicable
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From start of treatment up to 96 hours post single, intravenous dosePopulation: Bleeding events were assessed in the Safety Analysis Set.
Non-ICH was defined as a clinically evident bleeding with a 5 g/dL or greater decrease in hemoglobin.
Outcome measures
| Measure |
DS-1040b 0.6 mg
n=6 Participants
Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
|
DS-1040b 1.2 mg
n=12 Participants
Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
|
DS-1040b 2.4 mg
n=11 Participants
Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
|
DS-1040b 4.8 mg
n=3 Participants
Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
|
Placebo
n=9 Participants
Participants who received a single, intravenous infusion of placebo.
|
|---|---|---|---|---|---|
|
Number of Participants With Non-ICH Major Bleeding Within 96 Hours From Start of Treatment With DS-1040b In Acute Ischemic Stroke Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dosePopulation: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
The pharmacokinetic (PK) parameter of area under the plasma concentration-time curve up to the last quantifiable time was calculated using linear up logarithmic down rule.
Outcome measures
| Measure |
DS-1040b 0.6 mg
n=6 Participants
Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
|
DS-1040b 1.2 mg
n=11 Participants
Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
|
DS-1040b 2.4 mg
n=10 Participants
Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
|
DS-1040b 4.8 mg
n=3 Participants
Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
|
Placebo
Participants who received a single, intravenous infusion of placebo.
|
|---|---|---|---|---|---|
|
Pharmacokinetic Analysis Area Under The Plasma Concentration Time Curve (AUC) of DS-1040a in Plasma
|
111 ng*h/mL
Standard Deviation 45.5
|
275 ng*h/mL
Standard Deviation 72.2
|
570 ng*h/mL
Standard Deviation 230
|
1550 ng*h/mL
Standard Deviation 962
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dosePopulation: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
The PK parameter of maximum concentration (Cmax) was observed values.
Outcome measures
| Measure |
DS-1040b 0.6 mg
n=6 Participants
Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
|
DS-1040b 1.2 mg
n=11 Participants
Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
|
DS-1040b 2.4 mg
n=10 Participants
Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
|
DS-1040b 4.8 mg
n=3 Participants
Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
|
Placebo
Participants who received a single, intravenous infusion of placebo.
|
|---|---|---|---|---|---|
|
Pharmacokinetic Analysis Maximum Concentration (Cmax) of DS-1040a in Plasma
|
17.2 ng/mL
Standard Deviation 6.25
|
29.7 ng/mL
Standard Deviation 7.50
|
60.6 ng/mL
Standard Deviation 11.8
|
141 ng/mL
Standard Deviation 61.7
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dosePopulation: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
The PK parameter of time to maximum concentration (Tmax) was observed values. When there are more than one time point, the time point when the concentration reached the first Cmax will be used as Tmax.
Outcome measures
| Measure |
DS-1040b 0.6 mg
n=6 Participants
Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
|
DS-1040b 1.2 mg
n=11 Participants
Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
|
DS-1040b 2.4 mg
n=10 Participants
Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
|
DS-1040b 4.8 mg
n=3 Participants
Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
|
Placebo
Participants who received a single, intravenous infusion of placebo.
|
|---|---|---|---|---|---|
|
Pharmacokinetic Analysis Time to Maximum Concentration (Tmax) of DS-1040b in Plasma
|
2.21 hours
Standard Deviation 2.18
|
4.67 hours
Standard Deviation 2.29
|
5.11 hours
Standard Deviation 1.85
|
5.96 hours
Standard Deviation 0.03
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dosePopulation: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis set in participants with available sample for analysis.
The PK parameter of terminal half-life (T1/2) was calculated from the following formula in participants whose Kel could be calculated. T1/2=ln2 / Kel
Outcome measures
| Measure |
DS-1040b 0.6 mg
n=1 Participants
Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
|
DS-1040b 1.2 mg
n=3 Participants
Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
|
DS-1040b 2.4 mg
n=5 Participants
Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
|
DS-1040b 4.8 mg
n=3 Participants
Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
|
Placebo
Participants who received a single, intravenous infusion of placebo.
|
|---|---|---|---|---|---|
|
Pharmacokinetic Analysis Terminal Half-Life (T1/2) of DS-1040b in Plasma
|
4.61 hours
|
16.8 hours
Standard Deviation 1.74
|
19.5 hours
Standard Deviation 10.5
|
29.7 hours
Standard Deviation 2.35
|
—
|
SECONDARY outcome
Timeframe: From start of treatment up to 24 hours post single, intravenous dosePopulation: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set in participants with available sample for analysis.
The pharmacokinetic parameter of amount of drug excreted in urine was calculated from the following formula: urine concentration (ng/mL) /10\^6× (urine weight / urinary specific gravity)
Outcome measures
| Measure |
DS-1040b 0.6 mg
n=6 Participants
Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
|
DS-1040b 1.2 mg
n=9 Participants
Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
|
DS-1040b 2.4 mg
n=10 Participants
Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
|
DS-1040b 4.8 mg
n=3 Participants
Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
|
Placebo
Participants who received a single, intravenous infusion of placebo.
|
|---|---|---|---|---|---|
|
Pharmacokinetic Analysis Mean Amount of DS-1040a Excreted in Urine in Acute Ischemic Stroke Participants
|
0.420 mg
Standard Deviation 0.0308
|
0.880 mg
Standard Deviation 0.0683
|
1.49 mg
Standard Deviation 0.309
|
3.45 mg
Standard Deviation 0.417
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 hours and 24 hours post single, intravenous dosePopulation: Pharmacodynamic parameters were assessed in the Pharmacodynamic Analysis Set.
The mean thrombin activatable fibrinolysis (TAFI) antigen levels and change from baseline in TAFI levels are reported. Change from baseline is based on the number of participants with baseline and at least one post-baseline laboratory test.
Outcome measures
| Measure |
DS-1040b 0.6 mg
n=6 Participants
Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
|
DS-1040b 1.2 mg
n=11 Participants
Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
|
DS-1040b 2.4 mg
n=10 Participants
Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
|
DS-1040b 4.8 mg
n=3 Participants
Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
|
Placebo
n=8 Participants
Participants who received a single, intravenous infusion of placebo.
|
|---|---|---|---|---|---|
|
Pharmacodynamic Analysis Thrombin Activatable Fibrinolysis Inhibitor (TAFI) Antigen Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants
24 hours postdose
|
87.75 % of normal pooled plasma control
Standard Deviation 20.938
|
78.09 % of normal pooled plasma control
Standard Deviation 11.033
|
77.62 % of normal pooled plasma control
Standard Deviation 14.208
|
72.70 % of normal pooled plasma control
Standard Deviation 8.681
|
79.11 % of normal pooled plasma control
Standard Deviation 13.051
|
|
Pharmacodynamic Analysis Thrombin Activatable Fibrinolysis Inhibitor (TAFI) Antigen Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants
Baseline
|
99.17 % of normal pooled plasma control
Standard Deviation 25.527
|
80.05 % of normal pooled plasma control
Standard Deviation 9.101
|
79.56 % of normal pooled plasma control
Standard Deviation 19.553
|
81.90 % of normal pooled plasma control
Standard Deviation 2.750
|
88.28 % of normal pooled plasma control
Standard Deviation 17.157
|
|
Pharmacodynamic Analysis Thrombin Activatable Fibrinolysis Inhibitor (TAFI) Antigen Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants
6 hours postdose
|
94.05 % of normal pooled plasma control
Standard Deviation 22.090
|
81.37 % of normal pooled plasma control
Standard Deviation 11.358
|
86.12 % of normal pooled plasma control
Standard Deviation 13.727
|
81.23 % of normal pooled plasma control
Standard Deviation 6.313
|
87.55 % of normal pooled plasma control
Standard Deviation 15.987
|
|
Pharmacodynamic Analysis Thrombin Activatable Fibrinolysis Inhibitor (TAFI) Antigen Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants
Change from baseline to 6 hour postdose
|
-5.12 % of normal pooled plasma control
Standard Deviation 6.463
|
1.69 % of normal pooled plasma control
Standard Deviation 5.077
|
1.28 % of normal pooled plasma control
Standard Deviation 8.551
|
-0.67 % of normal pooled plasma control
Standard Deviation 4.202
|
-0.73 % of normal pooled plasma control
Standard Deviation 5.579
|
|
Pharmacodynamic Analysis Thrombin Activatable Fibrinolysis Inhibitor (TAFI) Antigen Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants
Change from baseline to 24 hours postdose
|
-11.42 % of normal pooled plasma control
Standard Deviation 6.934
|
-1.95 % of normal pooled plasma control
Standard Deviation 9.641
|
-5.09 % of normal pooled plasma control
Standard Deviation 6.625
|
-9.20 % of normal pooled plasma control
Standard Deviation 6.070
|
-9.16 % of normal pooled plasma control
Standard Deviation 9.759
|
SECONDARY outcome
Timeframe: Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dosePopulation: Pharmacodynamic parameters were assessed in the Pharmacodynamic Analysis Set.
Mean D-dimer levels and change from baseline in D-dimer levels are reported.Change from baseline is based on the number of subjects with baseline and at least one post-baseline laboratory test.
Outcome measures
| Measure |
DS-1040b 0.6 mg
n=6 Participants
Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
|
DS-1040b 1.2 mg
n=11 Participants
Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
|
DS-1040b 2.4 mg
n=10 Participants
Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
|
DS-1040b 4.8 mg
n=3 Participants
Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
|
Placebo
n=8 Participants
Participants who received a single, intravenous infusion of placebo.
|
|---|---|---|---|---|---|
|
Pharmacodynamic Analysis D-dimer Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants
Change from baseline to 48 hours postdose
|
-0.693 ug/mL FEU
Standard Deviation 1.6989
|
0.163 ug/mL FEU
Standard Deviation 0.2431
|
1.033 ug/mL FEU
Standard Deviation 2.4047
|
0.673 ug/mL FEU
Standard Deviation 0.8559
|
0.260 ug/mL FEU
Standard Deviation 0.4700
|
|
Pharmacodynamic Analysis D-dimer Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants
Baseline
|
1.600 ug/mL FEU
Standard Deviation 2.8865
|
0.730 ug/mL FEU
Standard Deviation 0.4176
|
2.423 ug/mL FEU
Standard Deviation 4.8964
|
0.613 ug/mL FEU
Standard Deviation 0.1250
|
3.096 ug/mL FEU
Standard Deviation 6.8343
|
|
Pharmacodynamic Analysis D-dimer Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants
6 hours postdose
|
1.368 ug/mL FEU
Standard Deviation 2.1428
|
0.717 ug/mL FEU
Standard Deviation 0.4899
|
3.254 ug/mL FEU
Standard Deviation 6.3573
|
1.090 ug/mL FEU
Standard Deviation 0.4540
|
3.436 ug/mL FEU
Standard Deviation 7.3095
|
|
Pharmacodynamic Analysis D-dimer Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants
24 hours postdose
|
1.158 ug/mL FEU
Standard Deviation 1.6216
|
0.960 ug/mL FEU
Standard Deviation 0.7254
|
2.879 ug/mL FEU
Standard Deviation 6.0571
|
1.067 ug/mL FEU
Standard Deviation 0.5235
|
3.731 ug/mL FEU
Standard Deviation 7.1964
|
|
Pharmacodynamic Analysis D-dimer Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants
48 hours postdose
|
0.907 ug/mL FEU
Standard Deviation 1.1908
|
0.912 ug/mL FEU
Standard Deviation 0.5107
|
2.668 ug/mL FEU
Standard Deviation 6.0954
|
1.287 ug/mL FEU
Standard Deviation 0.7371
|
0.941 ug/mL FEU
Standard Deviation 0.5545
|
|
Pharmacodynamic Analysis D-dimer Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants
Change from baseline to 6 hour postdose
|
-0.452 ug/mL FEU
Standard Deviation 1.0327
|
-0.008 ug/mL FEU
Standard Deviation 0.1091
|
1.497 ug/mL FEU
Standard Deviation 2.6031
|
0.477 ug/mL FEU
Standard Deviation 0.5742
|
-0.023 ug/mL FEU
Standard Deviation 0.1340
|
|
Pharmacodynamic Analysis D-dimer Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants
Change from baseline to 24 hours postdose
|
-0.442 ug/mL FEU
Standard Deviation 1.2701
|
0.217 ug/mL FEU
Standard Deviation 0.5241
|
1.180 ug/mL FEU
Standard Deviation 2.4023
|
0.453 ug/mL FEU
Standard Deviation 0.6422
|
0.284 ug/mL FEU
Standard Deviation 0.4342
|
SECONDARY outcome
Timeframe: Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dosePopulation: Pharmacodynamic parameters were assessed in the Pharmacodynamic Analysis Set.
Mean activated form of thrombin-activatable fibrinolysis inhibitor (TAFIa) and change from baseline in TAFIa are reported. Change from baseline is based on the number of subjects with baseline and at least one post-baseline laboratory test.
Outcome measures
| Measure |
DS-1040b 0.6 mg
n=6 Participants
Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
|
DS-1040b 1.2 mg
n=11 Participants
Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
|
DS-1040b 2.4 mg
n=10 Participants
Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
|
DS-1040b 4.8 mg
n=3 Participants
Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
|
Placebo
n=8 Participants
Participants who received a single, intravenous infusion of placebo.
|
|---|---|---|---|---|---|
|
Pharmacodynamic Analysis Activated Form of Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) Activity and Change From Baseline in Acute Ischemic Stroke Participants
6 hours postdose
|
110.4 % of normal pooled plasma control
Standard Deviation 28.10
|
77.9 % of normal pooled plasma control
Standard Deviation 18.52
|
82.7 % of normal pooled plasma control
Standard Deviation 16.49
|
68.7 % of normal pooled plasma control
Standard Deviation 10.97
|
95.5 % of normal pooled plasma control
Standard Deviation 21.63
|
|
Pharmacodynamic Analysis Activated Form of Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) Activity and Change From Baseline in Acute Ischemic Stroke Participants
24 hours postdose
|
93.4 % of normal pooled plasma control
Standard Deviation 29.03
|
78.7 % of normal pooled plasma control
Standard Deviation 14.58
|
90.7 % of normal pooled plasma control
Standard Deviation 18.67
|
91.7 % of normal pooled plasma control
Standard Deviation 7.51
|
88.0 % of normal pooled plasma control
Standard Deviation 16.00
|
|
Pharmacodynamic Analysis Activated Form of Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) Activity and Change From Baseline in Acute Ischemic Stroke Participants
48 hours postdose
|
91.2 % of normal pooled plasma control
Standard Deviation 27.01
|
70.0 % of normal pooled plasma control
Standard Deviation 7.09
|
84.7 % of normal pooled plasma control
Standard Deviation 17.50
|
88.7 % of normal pooled plasma control
Standard Deviation 6.66
|
87.6 % of normal pooled plasma control
Standard Deviation 13.96
|
|
Pharmacodynamic Analysis Activated Form of Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) Activity and Change From Baseline in Acute Ischemic Stroke Participants
Baseline
|
104.5 % of normal pooled plasma control
Standard Deviation 30.68
|
81.8 % of normal pooled plasma control
Standard Deviation 17.67
|
93.9 % of normal pooled plasma control
Standard Deviation 28.92
|
99.0 % of normal pooled plasma control
Standard Deviation 8.54
|
88.7 % of normal pooled plasma control
Standard Deviation 18.99
|
|
Pharmacodynamic Analysis Activated Form of Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) Activity and Change From Baseline in Acute Ischemic Stroke Participants
Change from baseline to 6 hours postdose
|
-1.4 % of normal pooled plasma control
Standard Deviation 11.04
|
-2.6 % of normal pooled plasma control
Standard Deviation 11.82
|
-14.6 % of normal pooled plasma control
Standard Deviation 16.00
|
-30.3 % of normal pooled plasma control
Standard Deviation 13.01
|
8.0 % of normal pooled plasma control
Standard Deviation 13.24
|
|
Pharmacodynamic Analysis Activated Form of Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) Activity and Change From Baseline in Acute Ischemic Stroke Participants
Change from baseline to 24 hours postdose
|
-6.2 % of normal pooled plasma control
Standard Deviation 7.56
|
-5.5 % of normal pooled plasma control
Standard Deviation 15.17
|
-6.4 % of normal pooled plasma control
Standard Deviation 12.03
|
-7.3 % of normal pooled plasma control
Standard Deviation 16.04
|
0.6 % of normal pooled plasma control
Standard Deviation 8.00
|
|
Pharmacodynamic Analysis Activated Form of Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) Activity and Change From Baseline in Acute Ischemic Stroke Participants
Change from baseline to 48 hours postdose
|
-13.3 % of normal pooled plasma control
Standard Deviation 9.99
|
-6.9 % of normal pooled plasma control
Standard Deviation 11.46
|
-11.0 % of normal pooled plasma control
Standard Deviation 10.92
|
-10.3 % of normal pooled plasma control
Standard Deviation 13.61
|
-1.1 % of normal pooled plasma control
Standard Deviation 13.95
|
Adverse Events
DS-1040b 0.6 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
DS-1040b 1.2 mg
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
DS-1040b 2.4 mg
Serious events: 2 serious events
Other events: 10 other events
Deaths: 1 deaths
DS-1040b 4.8 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
DS-1040b 0.6 mg
n=6 participants at risk
Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
|
DS-1040b 1.2 mg
n=12 participants at risk
Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
|
DS-1040b 2.4 mg
n=11 participants at risk
Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
|
DS-1040b 4.8 mg
n=3 participants at risk
Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
|
Placebo
n=9 participants at risk
Participants who received a single, intravenous infusion of placebo.
|
|---|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
Other adverse events
| Measure |
DS-1040b 0.6 mg
n=6 participants at risk
Participants who received a single, intravenous infusion of DS-1040b 0.6 mg.
|
DS-1040b 1.2 mg
n=12 participants at risk
Participants who received a single, intravenous infusion of DS-1040b 1.2 mg.
|
DS-1040b 2.4 mg
n=11 participants at risk
Participants who received a single, intravenous infusion of DS-1040b 2.4 mg.
|
DS-1040b 4.8 mg
n=3 participants at risk
Participants who received a single, intravenous infusion of DS-1040b 4.8 mg.
|
Placebo
n=9 participants at risk
Participants who received a single, intravenous infusion of placebo.
|
|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
22.2%
2/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
22.2%
2/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Infections and infestations
Periodontis
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Infections and infestations
Respiratory moniliasis
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
16.7%
2/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
18.2%
2/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
16.7%
2/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Nervous system disorders
Parkinsonism
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Eye disorders
Eye discharge
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Vascular disorders
Haemorrhagic infarction
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
41.7%
5/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
18.2%
2/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
18.2%
2/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Vascular disorders
Internal haemorrhage
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
16.7%
2/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
16.7%
2/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
27.3%
3/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
33.3%
3/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Gastrointestinal disorders
Acetonaemic vomiting
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Gastrointestinal disorders
Lip haemorrhage
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
16.7%
2/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
22.2%
2/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
25.0%
3/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
18.2%
2/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Renal and urinary disorders
Haematuria
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
18.2%
2/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
General disorders
Vessel puncture site haematoma
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
General disorders
Vessel puncture site haemorrhage
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Investigations
Blood glucose increased
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Investigations
Blood pressure increased
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Investigations
ECG signs of myocardial ischaemia
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Investigations
Liver function test increased
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
22.2%
2/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Injury, poisoning and procedural complications
Pharyngeal injury
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Injury, poisoning and procedural complications
Urinary tract injury
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
9.1%
1/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/11 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.
A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place