Trial Outcomes & Findings for Dose Escalation Trial of Dalotuzumab (MK-0646) in Advanced Solid Tumors and Multiple Myeloma (MK-0646-001) (NCT NCT00701103)
NCT ID: NCT00701103
Last Updated: 2018-08-08
Results Overview
Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 3.0 (CTCAE 3.0). A DLT was defined as any Grade 3 or 4 toxicity. A Grade 3 toxicity was defined as severe or medically significant but not immediately life-threatening OR hospitalization or prolongation of hospitalization indicated OR disabling OR limiting self care activities of daily living. A Grade 4 toxicity was defined as: life-threatening consequences OR urgent intervention indicated. Participants were monitored for the occurrence of DLTs during the first 3 weeks of dosing with dalotuzumab.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
80 participants
Primary outcome timeframe
Up to 3 weeks
Results posted on
2018-08-08
Participant Flow
Participants who were ≥18 years old, had metastatic or locally advanced solid tumors (including multiple myeloma) and failed to respond to standard therapy, or had progressed despite standard therapy, or for whom standard therapy did not exist were recruited for this study.
Participant milestones
| Measure |
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) intravenous (IV) infusion 1 time every 1 week (Q1W).
|
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion 1 time every 2 weeks (Q2W).
|
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion 1 time every 3 weeks (Q3W).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
8
|
6
|
6
|
6
|
8
|
7
|
9
|
11
|
11
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
8
|
6
|
6
|
6
|
8
|
7
|
9
|
11
|
11
|
Reasons for withdrawal
| Measure |
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) intravenous (IV) infusion 1 time every 1 week (Q1W).
|
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion 1 time every 2 weeks (Q2W).
|
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion 1 time every 3 weeks (Q3W).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
1
|
1
|
0
|
0
|
2
|
0
|
|
Overall Study
Progressive Disease
|
5
|
2
|
6
|
5
|
6
|
5
|
7
|
7
|
8
|
8
|
11
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Dose Escalation Trial of Dalotuzumab (MK-0646) in Advanced Solid Tumors and Multiple Myeloma (MK-0646-001)
Baseline characteristics by cohort
| Measure |
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
n=5 Participants
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
n=3 Participants
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
n=8 Participants
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
n=6 Participants
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
n=6 Participants
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
n=6 Participants
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
n=8 Participants
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
n=7 Participants
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
n=9 Participants
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
n=11 Participants
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
|
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
n=11 Participants
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
69 Years
STANDARD_DEVIATION 9 • n=5 Participants
|
60 Years
STANDARD_DEVIATION 9 • n=7 Participants
|
68 Years
STANDARD_DEVIATION 9 • n=5 Participants
|
56 Years
STANDARD_DEVIATION 10 • n=4 Participants
|
53 Years
STANDARD_DEVIATION 17 • n=21 Participants
|
49 Years
STANDARD_DEVIATION 22 • n=10 Participants
|
54 Years
STANDARD_DEVIATION 18 • n=115 Participants
|
46 Years
STANDARD_DEVIATION 13 • n=6 Participants
|
52 Years
STANDARD_DEVIATION 18 • n=6 Participants
|
55 Years
STANDARD_DEVIATION 17 • n=64 Participants
|
52 Years
STANDARD_DEVIATION 15 • n=17 Participants
|
55 Years
STANDARD_DEVIATION 16 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=64 Participants
|
6 Participants
n=17 Participants
|
40 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
5 Participants
n=17 Participants
|
40 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 3 weeksPopulation: The population consisted of all participants who received at least one dose of study drug.
Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 3.0 (CTCAE 3.0). A DLT was defined as any Grade 3 or 4 toxicity. A Grade 3 toxicity was defined as severe or medically significant but not immediately life-threatening OR hospitalization or prolongation of hospitalization indicated OR disabling OR limiting self care activities of daily living. A Grade 4 toxicity was defined as: life-threatening consequences OR urgent intervention indicated. Participants were monitored for the occurrence of DLTs during the first 3 weeks of dosing with dalotuzumab.
Outcome measures
| Measure |
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
n=5 Participants
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
n=3 Participants
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
n=8 Participants
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
n=6 Participants
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
n=6 Participants
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
n=6 Participants
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
n=8 Participants
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
n=7 Participants
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
n=9 Participants
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
n=11 Participants
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
|
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
n=11 Participants
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced One or More Dose-limiting Toxicities (DLTs)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
13 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusionPopulation: The population consisted of all evaluable participants who received \>90% of intended drug volume and had t1/2 pharmacokinetic measurements at Baseline and at least once during treatment.
Terminal half-life is defined as the time it takes for the blood plasma concentration of a substance to halve (plasma half-life). Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post infusion. For infusions \>1 hour in duration, an additional sample was obtained at the mid-point of the infusion. Data presented are for the harmonic mean t1/2 for dalotuzumab.
Outcome measures
| Measure |
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
n=5 Participants
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
n=3 Participants
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
n=8 Participants
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
n=6 Participants
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
n=3 Participants
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
n=6 Participants
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
n=8 Participants
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
n=7 Participants
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
n=9 Participants
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
n=11 Participants
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
|
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
n=11 Participants
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Terminal Half-life (t1/2) of Dalotuzumab
|
67 Hours
Interval 46.0 to 121.0
|
79 Hours
Interval 53.0 to 113.0
|
83 Hours
Interval 41.0 to 240.0
|
169 Hours
Interval 134.0 to 265.0
|
100 Hours
Interval 81.0 to 123.0
|
95 Hours
Interval 43.0 to 165.0
|
110 Hours
Interval 83.0 to 215.0
|
129 Hours
Interval 74.0 to 240.0
|
120 Hours
Interval 66.0 to 184.0
|
106 Hours
Interval 44.0 to 134.0
|
142 Hours
Interval 73.0 to 187.0
|
PRIMARY outcome
Timeframe: Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusionPopulation: The population consisted of all evaluable participants who received \>90% of intended drug volume and had AUC0-last pharmacokinetic measurements at Baseline and at least once during treatment.
AUC0-∞ represents the total drug exposure over time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion. For infusions \>1 hour in duration, an additional sample was obtained at the mid-point of the infusion.
Outcome measures
| Measure |
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
n=5 Participants
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
n=3 Participants
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
n=8 Participants
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
n=6 Participants
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
n=3 Participants
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
n=6 Participants
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
n=8 Participants
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
n=7 Participants
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
n=9 Participants
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
n=11 Participants
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
|
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
n=11 Participants
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Time-concentration Curve From 0 to Infinity Hours (AUC0-∞) of Dalotuzumab
|
1.6 mg*hr/mL
Standard Deviation 0.4
|
3.7 mg*hr/mL
Standard Deviation 1.1
|
12.9 mg*hr/mL
Standard Deviation 4.4
|
28.9 mg*hr/mL
Standard Deviation 10.4
|
18.4 mg*hr/mL
Standard Deviation 4.1
|
39.4 mg*hr/mL
Standard Deviation 14.5
|
28.8 mg*hr/mL
Standard Deviation 8.8
|
52.7 mg*hr/mL
Standard Deviation 19.2
|
44.3 mg*hr/mL
Standard Deviation 20.0
|
45.9 mg*hr/mL
Standard Deviation 14.4
|
92.6 mg*hr/mL
Standard Deviation 29.8
|
PRIMARY outcome
Timeframe: Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusionPopulation: The population consisted of all evaluable participants who received \>90% of intended drug volume and had mean serum clearance pharmacokinetic measurements at Baseline and at least once during treatment.
Clearance is defined as the volume of serum from which study drug was completely removed per unit of time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post infusion. For infusions \>1 hour in duration, an additional sample was obtained at the mid-point of the infusion.
Outcome measures
| Measure |
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
n=5 Participants
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
n=3 Participants
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
n=8 Participants
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
n=6 Participants
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
n=3 Participants
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
n=6 Participants
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
n=8 Participants
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
n=7 Participants
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
n=9 Participants
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
n=11 Participants
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
|
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
n=11 Participants
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Serum Clearance of Dalotuzumab
|
0.013 mL/min/kg
Standard Deviation 0.004
|
0.012 mL/min/kg
Standard Deviation 0.003
|
0.007 mL/min/kg
Standard Deviation 0.003
|
0.006 mL/min/kg
Standard Deviation 0.002
|
0.009 mL/min/kg
Standard Deviation 0.002
|
0.007 mL/min/kg
Standard Deviation 0.004
|
0.010 mL/min/kg
Standard Deviation 0.004
|
0.007 mL/min/kg
Standard Deviation 0.003
|
0.009 mL/min/kg
Standard Deviation 0.004
|
0.008 mL/min/kg
Standard Deviation 0.003
|
0.006 mL/min/kg
Standard Deviation 0.003
|
PRIMARY outcome
Timeframe: Pre-dose immediately prior to second infusion: 168 hours for Q1W, 336 hours for Q2W and 504 hours for Q3W dosingPopulation: The population consisted of all evaluable participants who received \>90% of intended drug volume and had mean trough serum concentration pharmacokinetic measurements at Baseline and at least once during treatment.
The lowest (trough) concentration of dalotuzumab prior to the next dose of dalotuzumab was measured.
Outcome measures
| Measure |
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
n=5 Participants
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
n=3 Participants
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
n=8 Participants
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
n=6 Participants
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
n=3 Participants
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
n=6 Participants
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
n=8 Participants
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
n=7 Participants
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
n=9 Participants
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
n=11 Participants
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
|
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
n=11 Participants
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Trough Serum Concentration (Ctrough) of Dalotuzumab
|
2.4 ug/mL
Standard Deviation 2.2
|
7.2 ug/mL
Standard Deviation 3.0
|
21.2 ug/mL
Standard Deviation 8.3
|
54.8 ug/mL
Standard Deviation 13.3
|
45.2 ug/mL
Standard Deviation 17.4
|
81.2 ug/mL
Standard Deviation 38.6
|
59.6 ug/mL
Standard Deviation 17.3
|
110.5 ug/mL
Standard Deviation 46.0
|
87.3 ug/mL
Standard Deviation 41.5
|
57.0 ug/mL
Standard Deviation 22.7
|
70.4 ug/mL
Standard Deviation 34.1
|
SECONDARY outcome
Timeframe: Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)Population: The population consisted of all evaluable participants who received \>90% of intended drug volume and had skin IGF-1R pharmacodynamics measurements at Baseline and at least once during treatment. No data were available for the Dalotuzumab 30 mg/kg Q3W treatment group.
IGF-1R expression was measured in pre- and post-dose skin biopsy samples using an immunohistochemistry (IHC) assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.
Outcome measures
| Measure |
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
n=3 Participants
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
n=3 Participants
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
n=7 Participants
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
n=11 Participants
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
n=10 Participants
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
n=15 Participants
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
|
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Expression Level H-score in Skin Samples
Baseline
|
186.7 H-score
Standard Deviation 35.1
|
203.3 H-score
Standard Deviation 55.1
|
218.6 H-score
Standard Deviation 57.9
|
171.8 H-score
Standard Deviation 40.2
|
182.0 H-score
Standard Deviation 33.9
|
146.3 H-score
Standard Deviation 76.9
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Expression Level H-score in Skin Samples
Change from Baseline
|
-1.7 H-score
Standard Deviation 42.5
|
-11.7 H-score
Standard Deviation 48.6
|
-20.0 H-score
Standard Deviation 68.6
|
-2.7 H-score
Standard Deviation 42.2
|
-39.0 H-score
Standard Deviation 36.3
|
-27.0 H-score
Standard Deviation 54.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)Population: The population consisted of all evaluable participants who received \>90% of intended drug volume and had IGF-1R tumor pharmacodynamics measurements at Baseline and at least once during treatment. No data were available for the Dalotuzumab 2.5 mg/kg Q1W and Dalotuzumab 30 mg/kg Q3W treatment groups.
IGF-1R expression was measured in pre- and post-dose tumor biopsy samples using an IHC assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.
Outcome measures
| Measure |
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
n=2 Participants
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
n=5 Participants
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
n=4 Participants
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
n=7 Participants
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
n=15 Participants
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
|
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in IGF-1R Protein Expression Level H-score in Tumor Samples
Baseline
|
145.0 H-score
Standard Deviation 91.9
|
—
|
84.0 H-score
Standard Deviation 59.0
|
110.0 H-score
Standard Deviation 46.9
|
134.3 H-score
Standard Deviation 77.0
|
152.5 H-score
Standard Deviation 72.4
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in IGF-1R Protein Expression Level H-score in Tumor Samples
Change from Baseline
|
-80.0 H-score
Standard Deviation 28.3
|
—
|
-16.0 H-score
Standard Deviation 27.0
|
10.0 H-score
Standard Deviation 76.2
|
-30.0 H-score
Standard Deviation 40.0
|
-40.8 H-score
Standard Deviation 108.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: The population consisted of all participants who received \>90% of intended drug volume and had measurements at Baseline and at least once during treatment.
It is thought that the formation of HAHAs may block efficacy by prematurely clearing dalotuzumab and limit the possibility of future dalotuzumab therapy. Blood samples for the measurement of serum levels of HAHAs were obtained prior to treatment with dalotuzumab, and pre-dose Week 2 (Q1W), pre-dose Week 3 (Q2W), pre-dose Week 4 (QW3), pre-dose Week 5 (Q1W/Q2W), pre-dose Week 7 (Q2W/Q3W), pre-dose Week 9 (Q2W), pre-dose Week 10 (QW3) and pre-dose every 4 subsequent weeks and end of treatment (post-study: 4 weeks after last dose of study drug).
Outcome measures
| Measure |
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
n=5 Participants
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
n=3 Participants
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
n=8 Participants
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
n=6 Participants
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
n=6 Participants
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
n=6 Participants
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
n=8 Participants
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
n=7 Participants
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
n=9 Participants
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
n=11 Participants
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
|
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
n=11 Participants
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Developed a Serum Human-anti-humanized-antibody (HAHA) Response to Dalotuzumab
|
40 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
14 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: The population consisted of all evaluable participants who received \>90% of intended drug volume and had efficacy measurements at Baseline and at least once during treatment.
Tumor responses were measured by using Response Evaluation Criteria in Solid Tumors (RECIST) criteria in participants with solid tumors and using European Group for Blood and Marrow Transplantation (EBMT) criteria in participants with multiple myeloma. RECIST criteria for CR: Disappearance of all target lesions. RECIST criteria for PR: ≥30% decrease in the sum of diameters of target lesions. EBMT criteria for CR: Disappearance of the original mAb protein from the blood and urine AND \<5% plasma cells in the bone marrow AND no increase in the size or number of lytic bone lesions AND disappearance of soft tissue plasmacytomas AND normal serum calcium levels. EMBT criteria for PR: ≥50% reduction in the serum mAb protein level AND if a urine M-component is present, a reduction in 24-hour urinary light chain excretion by either ≥90% or to \<200 mg AND ≥50% reduction in the size of soft tissue plasmacytomas AND no increase in size or number of lytic bone lesions.
Outcome measures
| Measure |
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
n=5 Participants
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
n=3 Participants
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
n=8 Participants
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
n=6 Participants
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
n=6 Participants
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
n=6 Participants
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
n=8 Participants
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
n=7 Participants
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
n=9 Participants
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
n=11 Participants
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
|
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
n=11 Participants
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced a Complete Response (CR) or Partial Response (PR)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
Adverse Events
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
n=5 participants at risk
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
n=3 participants at risk
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
n=8 participants at risk
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
n=6 participants at risk
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
n=6 participants at risk
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
n=6 participants at risk
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
n=8 participants at risk
Participants received dalotuzumab 15 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
n=7 participants at risk
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
n=9 participants at risk
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
n=11 participants at risk
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
|
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
n=11 participants at risk
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ewing's sarcoma
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
n=5 participants at risk
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
n=3 participants at risk
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
n=8 participants at risk
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
n=6 participants at risk
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
n=6 participants at risk
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
n=6 participants at risk
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
n=8 participants at risk
Participants received dalotuzumab 15 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
n=7 participants at risk
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
n=9 participants at risk
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q1W.
|
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
n=11 participants at risk
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
|
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
n=11 participants at risk
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
20.0%
1/5 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Eye disorders
Diplopia
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
18.2%
2/11 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
18.2%
2/11 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
18.2%
2/11 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
27.3%
3/11 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
18.2%
2/11 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
18.2%
2/11 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
50.0%
4/8 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
37.5%
3/8 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
27.3%
3/11 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
45.5%
5/11 • Number of events 6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Infusion related reaction
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
20.0%
1/5 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
20.0%
1/5 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
18.2%
2/11 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
2/5 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
37.5%
3/8 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
18.2%
2/11 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
20.0%
1/5 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
20.0%
1/5 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Blood glucose increased
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
18.2%
2/11 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
20.0%
1/5 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Transaminases increased
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
44.4%
4/9 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
18.2%
2/11 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
33.3%
3/9 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
18.2%
2/11 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
18.2%
2/11 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
37.5%
3/8 • Number of events 8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
27.3%
3/11 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
1/5 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
20.0%
1/5 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
18.2%
2/11 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
20.0%
1/5 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
33.3%
3/9 • Number of events 6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/5 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/3 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/11 • Up to 30 days after last dose of study drug (Up to 25 months)
The population consisted of all participants who received at least one dose of study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER