Trial Outcomes & Findings for A Study of Alpharadin With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer (CRPC) (NCT NCT01106352)
NCT ID: NCT01106352
Last Updated: 2017-01-04
Results Overview
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
70 participants
Primary outcome timeframe
From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)
Results posted on
2017-01-04
Participant Flow
Study was conducted at seven study centers in United States and one study center in France, between 23 July 2010 (first subject first visit) and 16 June 2015 (last subject last visit).
A total of 70 subjects were enrolled in the study. Of these 17 were in the dose escalation cohort in three dose groups of radium-223 and docetaxel. The remaining 53 subjects were in expanded safety cohort, of them 46 were dosed; 33 received a combination of radium-223 dichloride plus docetaxel and 13 subjects received docetaxel alone.
Participant milestones
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
7
|
36
|
17
|
|
Overall Study
Started Dose Escalation
|
7
|
3
|
7
|
0
|
0
|
|
Overall Study
Completed Dose Escalation
|
6
|
3
|
5
|
0
|
0
|
|
Overall Study
Started Safety Cohort
|
0
|
0
|
0
|
36
|
17
|
|
Overall Study
Treated Safety Cohort
|
0
|
0
|
0
|
33
|
13
|
|
Overall Study
Completed Safety Cohort
|
0
|
0
|
0
|
23
|
9
|
|
Overall Study
COMPLETED
|
6
|
3
|
5
|
23
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
13
|
8
|
Reasons for withdrawal
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Subjects untreated
|
0
|
0
|
0
|
3
|
4
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Too ill to come in for the visit
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
3
|
1
|
|
Overall Study
Disease progression
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
3
|
2
|
|
Overall Study
Went on hospice
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Subject entered hospice
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Home hospice since July 2013
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Alpharadin With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer (CRPC)
Baseline characteristics by cohort
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=3 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
n=36 Participants
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
n=17 Participants
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
<18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
|
Age, Customized
Between 18 and 65 years
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
11 participants
n=4 Participants
|
7 participants
n=21 Participants
|
25 participants
n=10 Participants
|
|
Age, Customized
>65 years
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
25 participants
n=4 Participants
|
10 participants
n=21 Participants
|
45 participants
n=10 Participants
|
|
Gender
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Gender
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
70 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From randomization until 6 weeks post-injection in all dose cohort of dose-escalation partDLT was defined as - Absolute neutrophil count grade greater than or equal to (\>=) 4 (Common Terminology Criteria for Adverse Events \[CTCAE\], Version 4.0: less than \[\<\] 0.5 × 109 per Liter) lasting longer than 7 days without fever despite granulocyte colony-stimulating factor (G-CSF) support). Platelet count Grade \>= 4 (CTCAE, v4.0: \< 25× 109/L) lasting longer than 7 days. Diarrhea Grade \>= 3 (CTAE, v4.0: increase of \>= 7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared with baseline; limiting self-care in activities of daily living) in spite of optimal use of antidiarrheal medication. Vomiting or constipation Grade \>= 4 (CTCAE, v4.0: life-threatening consequences; urgent intervention indicated). Febrile neutropenia Grade \>= 3 (CTCAE, v4.0).
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=3 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Number of Subjects With Dose-Limiting Toxicities - Dose Escalation Part
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of study treatment to 6 weeks after study treatment (that is maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort) and 8 weeks for serious AEsPopulation: Only participants who received treatment were assessed
Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An Serious Adverse Event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in patient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=3 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
n=33 Participants
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
n=13 Participants
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4
TEAE CTCAE Grade 3
|
3 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4
TESAE
|
4 Participants
|
0 Participants
|
2 Participants
|
7 Participants
|
4 Participants
|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4
TEAE CTCAE Grade 4
|
2 Participants
|
1 Participants
|
1 Participants
|
10 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)Population: Only randomized participants who have this outcome measure tested were assessed
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=3 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
n=35 Participants
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
n=13 Participants
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period
Albumin Baseline (n= 7,3,7,35,13)
|
42 gram per liter (G/L)
Standard Deviation 3
|
43 gram per liter (G/L)
Standard Deviation 4
|
43 gram per liter (G/L)
Standard Deviation 3.56
|
42.7 gram per liter (G/L)
Standard Deviation 3.25
|
42.3 gram per liter (G/L)
Standard Deviation 4.09
|
|
Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period
Albumin: Change at Day 106 (n=1,0,0,27,11)
|
-2 gram per liter (G/L)
Standard Deviation NA
Standard deviation is not calculated.
|
NA gram per liter (G/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA gram per liter (G/L)
Standard Deviation NA
Mean Value is not calculated.
|
-1.3 gram per liter (G/L)
Standard Deviation 2.98
|
-1.2 gram per liter (G/L)
Standard Deviation 2.75
|
|
Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period
Albumin: Change at Day 190 (n= 0,0,0,24,6)
|
NA gram per liter (G/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA gram per liter (G/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA gram per liter (G/L)
Standard Deviation NA
Mean Value is not calculated.
|
-2.3 gram per liter (G/L)
Standard Deviation 3.33
|
-0.5 gram per liter (G/L)
Standard Deviation 2.07
|
|
Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period
Protein: Baseline (n= 7,3,7,35,13)
|
70.3 gram per liter (G/L)
Standard Deviation 4.23
|
69.7 gram per liter (G/L)
Standard Deviation 8.5
|
70.4 gram per liter (G/L)
Standard Deviation 4.89
|
68.7 gram per liter (G/L)
Standard Deviation 4.45
|
69.1 gram per liter (G/L)
Standard Deviation 5.33
|
|
Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period
Protein: Change at Day 106 (n=1,0,0,27,11 )
|
1 gram per liter (G/L)
Standard Deviation NA
Standard deviation is not calculated.
|
NA gram per liter (G/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA gram per liter (G/L)
Standard Deviation NA
Mean Value is not calculated.
|
-3.9 gram per liter (G/L)
Standard Deviation 3.79
|
-3.8 gram per liter (G/L)
Standard Deviation 2.56
|
|
Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period
Protein: Change at Day 190 (n= 0,0,0,24,6)
|
NA gram per liter (G/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA gram per liter (G/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA gram per liter (G/L)
Standard Deviation NA
Mean Value is not calculated.
|
-5.3 gram per liter (G/L)
Standard Deviation 3.63
|
-3.7 gram per liter (G/L)
Standard Deviation 4.18
|
|
Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period
Hemoglobin: Baseline (n= 7,3,7,35,13)
|
122.43 gram per liter (G/L)
Standard Deviation 14.581
|
120.67 gram per liter (G/L)
Standard Deviation 16.166
|
120.43 gram per liter (G/L)
Standard Deviation 8.522
|
122.82 gram per liter (G/L)
Standard Deviation 10.939
|
120.23 gram per liter (G/L)
Standard Deviation 12.05
|
|
Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period
Hemoglobin: Change at Day 106 (n=1,0,0,27,11 )
|
-10 gram per liter (G/L)
Standard Deviation NA
Standard deviation is not calculated.
|
NA gram per liter (G/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA gram per liter (G/L)
Standard Deviation NA
Mean Value is not calculated.
|
-8.81 gram per liter (G/L)
Standard Deviation 8.2
|
-14.27 gram per liter (G/L)
Standard Deviation 9.067
|
|
Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period
Hemoglobin: Change at Day 190 (n= 0,0,0,23,6)
|
NA gram per liter (G/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA gram per liter (G/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA gram per liter (G/L)
Standard Deviation NA
Mean Value is not calculated.
|
-13.65 gram per liter (G/L)
Standard Deviation 10.853
|
-10.67 gram per liter (G/L)
Standard Deviation 13.794
|
PRIMARY outcome
Timeframe: Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)Population: Only participants who received treatment were assessed
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=3 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
n=33 Participants
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
n=17 Participants
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period
AP: Baseline (n= 7,3,7,33,13)
|
533.1 units per liter (U/L)
Standard Deviation 656.36
|
144 units per liter (U/L)
Standard Deviation 89.2
|
224.6 units per liter (U/L)
Standard Deviation 115.08
|
218.2 units per liter (U/L)
Standard Deviation 207.63
|
195.9 units per liter (U/L)
Standard Deviation 110.86
|
|
Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period
AP: Change at Day 106 (n=1,0,0,27,11)
|
-134 units per liter (U/L)
Standard Deviation NA
Standard deviation is not calculated.
|
NA units per liter (U/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA units per liter (U/L)
Standard Deviation NA
Mean Value is not calculated.
|
-119.6 units per liter (U/L)
Standard Deviation 153.1
|
-78.9 units per liter (U/L)
Standard Deviation 46.35
|
|
Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period
AP: Change at Day 190 (n= 0,0,0,24,6)
|
NA units per liter (U/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA units per liter (U/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA units per liter (U/L)
Standard Deviation NA
Mean Value is not calculated.
|
-119.3 units per liter (U/L)
Standard Deviation 112.21
|
-116.8 units per liter (U/L)
Standard Deviation 52.21
|
|
Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period
AAT: Baseline (n= 7,3,7,33,13)
|
17.6 units per liter (U/L)
Standard Deviation 5.68
|
17 units per liter (U/L)
Standard Deviation 6.56
|
18.9 units per liter (U/L)
Standard Deviation 5.9
|
19.8 units per liter (U/L)
Standard Deviation 9.82
|
19.8 units per liter (U/L)
Standard Deviation 10.78
|
|
Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period
AAT: Change at Day 106 (n=1,0,0,27,11 )
|
100 units per liter (U/L)
Standard Deviation NA
Standard deviation is not calculated.
|
NA units per liter (U/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA units per liter (U/L)
Standard Deviation NA
Mean Value is not calculated.
|
2.9 units per liter (U/L)
Standard Deviation 13.54
|
-2.2 units per liter (U/L)
Standard Deviation 11.75
|
|
Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period
AAT: Change at Day 190 (n= 0,0,0,24,6)
|
NA units per liter (U/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA units per liter (U/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA units per liter (U/L)
Standard Deviation NA
Mean Value is not calculated.
|
1.1 units per liter (U/L)
Standard Deviation 8.67
|
-3.7 units per liter (U/L)
Standard Deviation 13.81
|
|
Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period
LD: Baseline (n= 7,3,7,33,13)
|
313.3 units per liter (U/L)
Standard Deviation 243.9
|
179 units per liter (U/L)
Standard Deviation 22.52
|
214.4 units per liter (U/L)
Standard Deviation 38.92
|
212.8 units per liter (U/L)
Standard Deviation 71.07
|
203.4 units per liter (U/L)
Standard Deviation 61.68
|
|
Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period
LD: Change at Day 106 (n= 1,0,0,27,11)
|
15 units per liter (U/L)
Standard Deviation NA
Standard deviation is not calculated.
|
NA units per liter (U/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA units per liter (U/L)
Standard Deviation NA
Mean Value is not calculated.
|
10.7 units per liter (U/L)
Standard Deviation 58.14
|
45.1 units per liter (U/L)
Standard Deviation 93.58
|
|
Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period
LD: Change at Day 190 (n= 0,0,0,24,6)
|
NA units per liter (U/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA units per liter (U/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA units per liter (U/L)
Standard Deviation NA
Mean Value is not calculated.
|
16.9 units per liter (U/L)
Standard Deviation 39.74
|
17.5 units per liter (U/L)
Standard Deviation 100.85
|
PRIMARY outcome
Timeframe: Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)Population: Only participants who received treatment were assessed
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=3 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
n=33 Participants
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
n=13 Participants
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period
Bilirubin: Baseline (n= 7,3,7,33,13)
|
8.9 micromole(s)/litre
Standard Deviation 3.8
|
6.7 micromole(s)/litre
Standard Deviation 1.15
|
7.1 micromole(s)/litre
Standard Deviation 3.98
|
7.5 micromole(s)/litre
Standard Deviation 2.62
|
7 micromole(s)/litre
Standard Deviation 2.08
|
|
Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period
Bilirubin: Change at Day 106 (n= 1,0,0,27,11)
|
2 micromole(s)/litre
Standard Deviation NA
Standard deviation is not calculated.
|
NA micromole(s)/litre
Standard Deviation NA
Mean Value is not calculated.
|
NA micromole(s)/litre
Standard Deviation NA
Mean Value is not calculated.
|
0.2 micromole(s)/litre
Standard Deviation 1.84
|
-0.8 micromole(s)/litre
Standard Deviation 1.72
|
|
Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period
Bilirubin: Change at Day 190 (n= 0,0,0,24,6)
|
NA micromole(s)/litre
Standard Deviation NA
Mean Value is not calculated.
|
NA micromole(s)/litre
Standard Deviation NA
Mean Value is not calculated.
|
NA micromole(s)/litre
Standard Deviation NA
Mean Value is not calculated.
|
-0.9 micromole(s)/litre
Standard Deviation 1.56
|
0.3 micromole(s)/litre
Standard Deviation 1.51
|
|
Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period
Creatinine: Baseline (n= 7,3,7,33,13)
|
92.33 micromole(s)/litre
Standard Deviation 33.126
|
73.67 micromole(s)/litre
Standard Deviation 9.5
|
70.86 micromole(s)/litre
Standard Deviation 10.938
|
70.07 micromole(s)/litre
Standard Deviation 19.138
|
75.5 micromole(s)/litre
Standard Deviation 11.614
|
|
Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period
Creatinine: Change at Day 106 (n= 1,0,0,27,11)
|
63.6 micromole(s)/litre
Standard Deviation NA
Standard deviation is not calculated.
|
NA micromole(s)/litre
Standard Deviation NA
Mean Value is not calculated.
|
NA micromole(s)/litre
Standard Deviation NA
Mean Value is not calculated.
|
0.74 micromole(s)/litre
Standard Deviation 12.273
|
-0.7 micromole(s)/litre
Standard Deviation 7.232
|
|
Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period
Creatinine: Change at Day 190 (n= 0,0,0,24,6)
|
NA micromole(s)/litre
Standard Deviation NA
Mean Value is not calculated.
|
NA micromole(s)/litre
Standard Deviation NA
Mean Value is not calculated.
|
NA micromole(s)/litre
Standard Deviation NA
Mean Value is not calculated.
|
0.59 micromole(s)/litre
Standard Deviation 11.889
|
-0.17 micromole(s)/litre
Standard Deviation 13.31
|
PRIMARY outcome
Timeframe: Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)Population: Only participants who received treatment were assessed
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=3 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
n=33 Participants
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
n=13 Participants
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Potassium: Change at Day 106 (n= 1,0,0,27,11)
|
1.1 millimole(s)/liter
Standard Deviation NA
Standard deviation is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
0.06 millimole(s)/liter
Standard Deviation 0.366
|
0.11 millimole(s)/liter
Standard Deviation 0.336
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Sodium: Baseline (n= 7,3,7,33,13)
|
136.1 millimole(s)/liter
Standard Deviation 4.1
|
137.7 millimole(s)/liter
Standard Deviation 3.51
|
137.4 millimole(s)/liter
Standard Deviation 2.51
|
138.5 millimole(s)/liter
Standard Deviation 2.49
|
137.2 millimole(s)/liter
Standard Deviation 4.72
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Sodium: Change at Day 106 (n= 1,0,0,27,11)
|
0 millimole(s)/liter
Standard Deviation NA
Standard deviation is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
-0.6 millimole(s)/liter
Standard Deviation 2.28
|
0.8 millimole(s)/liter
Standard Deviation 2.56
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Urea: Baseline (n= 7,3,7,33,13)
|
9.14 millimole(s)/liter
Standard Deviation 3.092
|
7.83 millimole(s)/liter
Standard Deviation 1.041
|
6.79 millimole(s)/liter
Standard Deviation 2.059
|
7.03 millimole(s)/liter
Standard Deviation 2.304
|
7.78 millimole(s)/liter
Standard Deviation 2.312
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Calcium: Baseline (n= 7,3,7,33,13)
|
2.231 millimole(s)/liter
Standard Deviation 0.1523
|
2.38 millimole(s)/liter
Standard Deviation 0.0872
|
2.309 millimole(s)/liter
Standard Deviation 0.071
|
2.357 millimole(s)/liter
Standard Deviation 0.1121
|
2.307 millimole(s)/liter
Standard Deviation 0.1437
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Calcium: Change at Day 106 (n= 1,0,0,27,11)
|
0.2 millimole(s)/liter
Standard Deviation NA
Standard deviation is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
-0.065 millimole(s)/liter
Standard Deviation 0.148
|
-0.019 millimole(s)/liter
Standard Deviation 0.104
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Calcium: Change at Day 190 (n= 0,0,0,24,6)
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
-0.055 millimole(s)/liter
Standard Deviation 0.1225
|
-0.143 millimole(s)/liter
Standard Deviation 0.1536
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Chloride: Baseline (n= 7,3,7,33,13)
|
101.4 millimole(s)/liter
Standard Deviation 3.21
|
101.7 millimole(s)/liter
Standard Deviation 2.52
|
102 millimole(s)/liter
Standard Deviation 2.77
|
103.2 millimole(s)/liter
Standard Deviation 2.75
|
101.3 millimole(s)/liter
Standard Deviation 3.99
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Chloride: Change at Day 106 (n= 1,0,0,27,11)
|
-1.9 millimole(s)/liter
Standard Deviation NA
Standard deviation is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
0 millimole(s)/liter
Standard Deviation 2.72
|
1.5 millimole(s)/liter
Standard Deviation 2.38
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Chloride: Change at Day 190 (n= 0,0,0,24,6)
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
0 millimole(s)/liter
Standard Deviation 3.35
|
2.5 millimole(s)/liter
Standard Deviation 1.38
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Magnesium: Baseline (n= 7,3,7,33,13)
|
0.93 millimole(s)/liter
Standard Deviation 0.055
|
0.86 millimole(s)/liter
Standard Deviation 0
|
0.86 millimole(s)/liter
Standard Deviation 0.088
|
0.85 millimole(s)/liter
Standard Deviation 0.072
|
0.84 millimole(s)/liter
Standard Deviation 0.073
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Magnesium: Change at Day 106 (n= 1,0,0,27,11)
|
-4.4 millimole(s)/liter
Standard Deviation NA
Standard deviation is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
-0.02 millimole(s)/liter
Standard Deviation 0.058
|
-0.04 millimole(s)/liter
Standard Deviation 0.036
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Magnesium: Change at Day 190 (n= 0,0,0,24,6)
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
-0.01 millimole(s)/liter
Standard Deviation 0.079
|
-0.06 millimole(s)/liter
Standard Deviation 0.045
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Potassium: Baseline (n= 7,3,7,33,13)
|
4.34 millimole(s)/liter
Standard Deviation 0.541
|
4.47 millimole(s)/liter
Standard Deviation 0.306
|
4.39 millimole(s)/liter
Standard Deviation 0.09
|
4.29 millimole(s)/liter
Standard Deviation 0.277
|
4.3 millimole(s)/liter
Standard Deviation 0.443
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Potassium: Change at Day 190 (n= 0,0,0,24,6)
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
0.04 millimole(s)/liter
Standard Deviation 0.422
|
0.03 millimole(s)/liter
Standard Deviation 0.501
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Phosphate: Baseline (n= 7,3,7,33,13)
|
1.021 millimole(s)/liter
Standard Deviation 0.168
|
1.167 millimole(s)/liter
Standard Deviation 0.2466
|
0.993 millimole(s)/liter
Standard Deviation 0.369
|
1.058 millimole(s)/liter
Standard Deviation 0.1763
|
1.145 millimole(s)/liter
Standard Deviation 0.1844
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Phosphate: Change at Day 106 (n= 1,0,0,27,11)
|
0 millimole(s)/liter
Standard Deviation NA
Standard deviation is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
0.086 millimole(s)/liter
Standard Deviation 0.1369
|
-0.061 millimole(s)/liter
Standard Deviation 0.2287
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Phosphate: Change at Day 190 (n= 0,0,0,24,6)
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
0.128 millimole(s)/liter
Standard Deviation 0.1734
|
0.203 millimole(s)/liter
Standard Deviation 0.1813
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Sodium: Change at Day 190 (n= 0,0,0,24,6)
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
-0.5 millimole(s)/liter
Standard Deviation 2.41
|
2.3 millimole(s)/liter
Standard Deviation 1.37
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Urea: Change at Day 106 (n= 1,0,0,27,11)
|
1.5 millimole(s)/liter
Standard Deviation NA
Standard deviation is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
-0.26 millimole(s)/liter
Standard Deviation 1.587
|
-0.26 millimole(s)/liter
Standard Deviation 1.531
|
|
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
Urea: Change at Day 190 (n= 0,0,0,24,6)
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
NA millimole(s)/liter
Standard Deviation NA
Mean Value is not calculated.
|
-0.15 millimole(s)/liter
Standard Deviation 1.508
|
0.7 millimole(s)/liter
Standard Deviation 1.122
|
PRIMARY outcome
Timeframe: Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)Population: Only participants who received treatment were assessed
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=3 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
n=33 Participants
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
n=13 Participants
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Lymphocytes: Change at Day 106 (n= 1,0,0,27,11)
|
1.3 giga per liter (GI/L)
Standard Deviation NA
Standard deviation is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
-0.229 giga per liter (GI/L)
Standard Deviation 0.5593
|
-0.063 giga per liter (GI/L)
Standard Deviation 0.5129
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Lymphocytes: Change at Day 190 (n= 0,0,0,23,6)
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
-0.395 giga per liter (GI/L)
Standard Deviation 0.3917
|
-0.085 giga per liter (GI/L)
Standard Deviation 0.6832
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Neutrophils: Baseline (n= 7,3,7,33,13)
|
7.809 giga per liter (GI/L)
Standard Deviation 4.0998
|
4.71 giga per liter (GI/L)
Standard Deviation 1.54
|
7.359 giga per liter (GI/L)
Standard Deviation 2.7781
|
6.363 giga per liter (GI/L)
Standard Deviation 2.8618
|
5.205 giga per liter (GI/L)
Standard Deviation 2.1487
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Platelets: Change at Day 190 (n= 0,0,0,23,6)
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
-22 giga per liter (GI/L)
Standard Deviation 51.04
|
32.3 giga per liter (GI/L)
Standard Deviation 68.54
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Leukocytes: Baseline (n= 7,3,7,33,13)
|
9.13 giga per liter (GI/L)
Standard Deviation 4.43
|
5.83 giga per liter (GI/L)
Standard Deviation 1.858
|
8.34 giga per liter (GI/L)
Standard Deviation 2.783
|
7.67 giga per liter (GI/L)
Standard Deviation 2.871
|
6.71 giga per liter (GI/L)
Standard Deviation 2.308
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Leukocytes: Change at Day 106 (n= 1,0,0,27,11)
|
18.7 giga per liter (GI/L)
Standard Deviation NA
Standard deviation is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
-0.1 giga per liter (GI/L)
Standard Deviation 2.086
|
2.44 giga per liter (GI/L)
Standard Deviation 2.263
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Leukocytes: Change at Day 190 (n= 0,0,0,23,6)
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
-0.12 giga per liter (GI/L)
Standard Deviation 2.603
|
1.65 giga per liter (GI/L)
Standard Deviation 1.946
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Lymphocytes: Baseline (n= 7,3,7,33,13)
|
1.044 giga per liter (GI/L)
Standard Deviation 0.4687
|
1.003 giga per liter (GI/L)
Standard Deviation 0.45
|
0.81 giga per liter (GI/L)
Standard Deviation 0.4679
|
1.001 giga per liter (GI/L)
Standard Deviation 0.5902
|
1.068 giga per liter (GI/L)
Standard Deviation 0.5751
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Neutrophils: Change at Day 106 (n= 1,0,0,27,11)
|
517.3 giga per liter (GI/L)
Standard Deviation NA
Standard deviation is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
0.178 giga per liter (GI/L)
Standard Deviation 2.2991
|
2.622 giga per liter (GI/L)
Standard Deviation 2.5672
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Neutrophils: Change at Day 190 (n= 0,0,0,23,6)
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
0.341 giga per liter (GI/L)
Standard Deviation 2.4734
|
2.038 giga per liter (GI/L)
Standard Deviation 1.8799
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Monocytes: Baseline (n= 7,3,7,33,13)
|
0.224 giga per liter (GI/L)
Standard Deviation 0.2319
|
0.103 giga per liter (GI/L)
Standard Deviation 0.085
|
0.153 giga per liter (GI/L)
Standard Deviation 0.1379
|
0.243 giga per liter (GI/L)
Standard Deviation 0.2466
|
0.375 giga per liter (GI/L)
Standard Deviation 0.4203
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Monocytes: Change at Day 106 (n= 1,0,0,27,11)
|
0.12 giga per liter (GI/L)
Standard Deviation NA
Standard deviation is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
-0.011 giga per liter (GI/L)
Standard Deviation 0.2959
|
-0.111 giga per liter (GI/L)
Standard Deviation 0.4164
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Monocytes: Change at Day 190 (n= 0,0,0,23,6)
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
-0.014 giga per liter (GI/L)
Standard Deviation 0.3185
|
-0.27 giga per liter (GI/L)
Standard Deviation 0.2964
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Eosinophils: Baseline (n= 7,3,7,33,13)
|
0.04 giga per liter (GI/L)
Standard Deviation 0.0622
|
0.01 giga per liter (GI/L)
Standard Deviation 0.01
|
0.014 giga per liter (GI/L)
Standard Deviation 0.0151
|
0.054 giga per liter (GI/L)
Standard Deviation 0.0734
|
0.043 giga per liter (GI/L)
Standard Deviation 0.0407
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Eosinophils: Change at Day 106 (n= 1,0,0,27,11)
|
-0.12 giga per liter (GI/L)
Standard Deviation NA
Standard deviation is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
-0.043 giga per liter (GI/L)
Standard Deviation 0.0797
|
-0.008 giga per liter (GI/L)
Standard Deviation 0.0995
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Eosinophils: Change at Day 190 (n= 0,0,0,23,6)
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
-0.049 giga per liter (GI/L)
Standard Deviation 0.0786
|
-0.023 giga per liter (GI/L)
Standard Deviation 0.0186
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Basophils: Baseline (n= 7,3,7,33,13)
|
0.013 giga per liter (GI/L)
Standard Deviation 0.0221
|
0.007 giga per liter (GI/L)
Standard Deviation 0.0058
|
0.011 giga per liter (GI/L)
Standard Deviation 0.0107
|
0.012 giga per liter (GI/L)
Standard Deviation 0.0137
|
0.018 giga per liter (GI/L)
Standard Deviation 0.0121
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Basophils: Change at Day 106 (n= 1,0,0,27,11)
|
0.02 giga per liter (GI/L)
Standard Deviation NA
Standard deviation is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
0.001 giga per liter (GI/L)
Standard Deviation 0.0169
|
-0.001 giga per liter (GI/L)
Standard Deviation 0.0197
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Platelets: Baseline (n= 7,3,7,33,13)
|
214.1 giga per liter (GI/L)
Standard Deviation 58.05
|
196.3 giga per liter (GI/L)
Standard Deviation 51.64
|
266.6 giga per liter (GI/L)
Standard Deviation 77.43
|
259.6 giga per liter (GI/L)
Standard Deviation 69.39
|
240.6 giga per liter (GI/L)
Standard Deviation 52.17
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Platelets: Change at Day 106 (n= 1,0,0,27,11)
|
169 giga per liter (GI/L)
Standard Deviation NA
Standard deviation is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
-3.1 giga per liter (GI/L)
Standard Deviation 51.39
|
33 giga per liter (GI/L)
Standard Deviation 55.17
|
|
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
Basophils: Change at Day 190 (n= 0,0,0,23,6)
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA giga per liter (GI/L)
Standard Deviation NA
Mean Value is not calculated.
|
-0.003 giga per liter (GI/L)
Standard Deviation 0.0136
|
-0.015 giga per liter (GI/L)
Standard Deviation 0.0105
|
PRIMARY outcome
Timeframe: Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)Population: Only participants who received treatment were assessed
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=3 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
n=33 Participants
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
n=13 Participants
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period
Erythrocytes: Baseline (n= 7,3,7,33,13)
|
3.99 tetra per liter (TI/L)
Standard Deviation 0.376
|
3.9 tetra per liter (TI/L)
Standard Deviation 0.361
|
3.9 tetra per liter (TI/L)
Standard Deviation 0.327
|
3.98 tetra per liter (TI/L)
Standard Deviation 0.378
|
4.02 tetra per liter (TI/L)
Standard Deviation 0.519
|
|
Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period
Erythrocytes: Change at Day 190 (n= 0,0,0,23,6)
|
NA tetra per liter (TI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA tetra per liter (TI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA tetra per liter (TI/L)
Standard Deviation NA
Mean Value is not calculated.
|
-0.39 tetra per liter (TI/L)
Standard Deviation 0.287
|
-0.15 tetra per liter (TI/L)
Standard Deviation 0.653
|
|
Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period
Erythrocytes: Change at Day 106 (n= 1,0,0,27,11)
|
-0.4 tetra per liter (TI/L)
Standard Deviation NA
Standard deviation is not calculated.
|
NA tetra per liter (TI/L)
Standard Deviation NA
Mean Value is not calculated.
|
NA tetra per liter (TI/L)
Standard Deviation NA
Mean Value is not calculated.
|
-0.25 tetra per liter (TI/L)
Standard Deviation 0.233
|
-0.32 tetra per liter (TI/L)
Standard Deviation 0.429
|
PRIMARY outcome
Timeframe: From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)Population: Only participants who received treatment were assessed
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=3 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
n=33 Participants
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
n=13 Participants
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
SBP: Baseline (n= 7,3,7,33,13)
|
137.7 millimeters of mercury (mmHg)
Standard Deviation 9.11
|
113 millimeters of mercury (mmHg)
Standard Deviation 12.12
|
131.7 millimeters of mercury (mmHg)
Standard Deviation 13.07
|
139.2 millimeters of mercury (mmHg)
Standard Deviation 17.01
|
140.1 millimeters of mercury (mmHg)
Standard Deviation 10.85
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
SBP: Change at Day 22 (n= 6,3,7,33,13)
|
-2.7 millimeters of mercury (mmHg)
Standard Deviation 13.52
|
2.3 millimeters of mercury (mmHg)
Standard Deviation 5.51
|
-5 millimeters of mercury (mmHg)
Standard Deviation 12.32
|
-1.8 millimeters of mercury (mmHg)
Standard Deviation 19.66
|
-8.5 millimeters of mercury (mmHg)
Standard Deviation 19.53
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
SBP: Change at Day 43 (n= 6,3,7,32,13)
|
-8.7 millimeters of mercury (mmHg)
Standard Deviation 12.13
|
-3 millimeters of mercury (mmHg)
Standard Deviation 9.54
|
-0.9 millimeters of mercury (mmHg)
Standard Deviation 19.37
|
0.6 millimeters of mercury (mmHg)
Standard Deviation 18.15
|
-15.3 millimeters of mercury (mmHg)
Standard Deviation 13.91
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
SBP: Change at Day 64 (n= 6,3,6,30,13)
|
-9.8 millimeters of mercury (mmHg)
Standard Deviation 16.36
|
-11 millimeters of mercury (mmHg)
Standard Deviation 13.45
|
-4.2 millimeters of mercury (mmHg)
Standard Deviation 13.66
|
-2.5 millimeters of mercury (mmHg)
Standard Deviation 21.75
|
-10.1 millimeters of mercury (mmHg)
Standard Deviation 13.32
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
SBP: Change at Day 85 (n= 0,0,0,28,13)
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
-3.1 millimeters of mercury (mmHg)
Standard Deviation 16.55
|
-3.8 millimeters of mercury (mmHg)
Standard Deviation 17.19
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
SBP: Change at Day 127 (n= 0,0,0,27,8)
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
-4.6 millimeters of mercury (mmHg)
Standard Deviation 19.82
|
-13.4 millimeters of mercury (mmHg)
Standard Deviation 22.01
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
SBP: Change at Day 169 (n= 0,0,0,25,7)
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
-3.6 millimeters of mercury (mmHg)
Standard Deviation 16.58
|
-6.3 millimeters of mercury (mmHg)
Standard Deviation 17.85
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
SBP: Change at Day 190 (n= 0,0,0,24,6)
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
-8.1 millimeters of mercury (mmHg)
Standard Deviation 18.25
|
-10 millimeters of mercury (mmHg)
Standard Deviation 16.15
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
DBP: Change at Day 22 (n= 6,3,7,33,13)
|
-2.7 millimeters of mercury (mmHg)
Standard Deviation 10.67
|
8 millimeters of mercury (mmHg)
Standard Deviation 10.39
|
2.6 millimeters of mercury (mmHg)
Standard Deviation 7.57
|
0.3 millimeters of mercury (mmHg)
Standard Deviation 10.88
|
-6.2 millimeters of mercury (mmHg)
Standard Deviation 16.03
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
DBP: Change at Day 43 (n= 6,3,7,32,13)
|
-3.7 millimeters of mercury (mmHg)
Standard Deviation 6.65
|
2.7 millimeters of mercury (mmHg)
Standard Deviation 5.03
|
4.1 millimeters of mercury (mmHg)
Standard Deviation 8.13
|
-1.8 millimeters of mercury (mmHg)
Standard Deviation 12.17
|
-11.7 millimeters of mercury (mmHg)
Standard Deviation 10.89
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
DBP: Change at Day 85 (n= 0,0,0,28,13)
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
1.1 millimeters of mercury (mmHg)
Standard Deviation 10.99
|
-7.6 millimeters of mercury (mmHg)
Standard Deviation 11.2
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
DBP: Change at Day 127 (n= 0,0,0,27,8)
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
-1.4 millimeters of mercury (mmHg)
Standard Deviation 14.22
|
-8 millimeters of mercury (mmHg)
Standard Deviation 9.94
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
DBP: Change at Day 148 (n= 0,0,0,25,7)
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
-2 millimeters of mercury (mmHg)
Standard Deviation 12.19
|
-3.9 millimeters of mercury (mmHg)
Standard Deviation 8.36
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
DBP: Change at Day 169 (n= 0,0,0,25,7)
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
-1.2 millimeters of mercury (mmHg)
Standard Deviation 10.45
|
-9 millimeters of mercury (mmHg)
Standard Deviation 8.6
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
DBP: Change at Day 190 (n= 0,0,0,24,6)
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
-3.6 millimeters of mercury (mmHg)
Standard Deviation 12.8
|
-12 millimeters of mercury (mmHg)
Standard Deviation 8.92
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
SBP: Change at Day 106 (n= 0,0,0,28,12)
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
-6.7 millimeters of mercury (mmHg)
Standard Deviation 21.33
|
-10.4 millimeters of mercury (mmHg)
Standard Deviation 16.33
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
SBP: Change at Day 148 (n= 0,0,0,25,7)
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
-3.9 millimeters of mercury (mmHg)
Standard Deviation 20.09
|
-8.9 millimeters of mercury (mmHg)
Standard Deviation 18.02
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
DBP: Baseline (n= 7,3,7,33,13)
|
81.6 millimeters of mercury (mmHg)
Standard Deviation 5.68
|
62 millimeters of mercury (mmHg)
Standard Deviation 2
|
74.1 millimeters of mercury (mmHg)
Standard Deviation 8.86
|
76.1 millimeters of mercury (mmHg)
Standard Deviation 10.19
|
83 millimeters of mercury (mmHg)
Standard Deviation 11.17
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
DBP: Change at Day 64 (n= 6,3,6,30,13)
|
-8.7 millimeters of mercury (mmHg)
Standard Deviation 7.89
|
-1 millimeters of mercury (mmHg)
Standard Deviation 1.73
|
-0.2 millimeters of mercury (mmHg)
Standard Deviation 15.93
|
-1.4 millimeters of mercury (mmHg)
Standard Deviation 14.66
|
-8.7 millimeters of mercury (mmHg)
Standard Deviation 9.21
|
|
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
DBP: Change at Day 106 (n= 0,0,0,28,12)
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
NA millimeters of mercury (mmHg)
Standard Deviation NA
Mean Value is not calculated.
|
-0.8 millimeters of mercury (mmHg)
Standard Deviation 13.15
|
-7.9 millimeters of mercury (mmHg)
Standard Deviation 14.13
|
PRIMARY outcome
Timeframe: From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)Population: Only participants who received treatment were assessed
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=3 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
n=33 Participants
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
n=13 Participants
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Changes From Baseline in Respiratory Rate During the Treatment Period
Change at Day 64 (n= 6,3,6,30,13)
|
-0.5 breaths/min
Standard Deviation 2.81
|
0 breaths/min
Standard Deviation 4
|
-1 breaths/min
Standard Deviation 1.1
|
0.4 breaths/min
Standard Deviation 2.82
|
0.8 breaths/min
Standard Deviation 3
|
|
Changes From Baseline in Respiratory Rate During the Treatment Period
Change at Day 85 (n= 0,0,0,28,13)
|
NA breaths/min
Standard Deviation NA
Mean Value is not calculated.
|
NA breaths/min
Standard Deviation NA
Mean Value is not calculated.
|
NA breaths/min
Standard Deviation NA
Mean Value is not calculated.
|
0 breaths/min
Standard Deviation 3.32
|
-0.3 breaths/min
Standard Deviation 2.39
|
|
Changes From Baseline in Respiratory Rate During the Treatment Period
Change at Day 169 (n= 0,0,0,25,7)
|
NA breaths/min
Standard Deviation NA
Mean Value is not calculated.
|
NA breaths/min
Standard Deviation NA
Mean Value is not calculated.
|
NA breaths/min
Standard Deviation NA
Mean Value is not calculated.
|
-1 breaths/min
Standard Deviation 3.11
|
0.4 breaths/min
Standard Deviation 2.15
|
|
Changes From Baseline in Respiratory Rate During the Treatment Period
Change at Day 190 (n= 0,0,0,24,6)
|
NA breaths/min
Standard Deviation NA
Mean Value is not calculated.
|
NA breaths/min
Standard Deviation NA
Mean Value is not calculated.
|
NA breaths/min
Standard Deviation NA
Mean Value is not calculated.
|
0 breaths/min
Standard Deviation 4.79
|
-0.2 breaths/min
Standard Deviation 1.33
|
|
Changes From Baseline in Respiratory Rate During the Treatment Period
Baseline (n= 7,3,7,33,13)
|
19.3 breaths/min
Standard Deviation 1.63
|
18.7 breaths/min
Standard Deviation 2.31
|
19.1 breaths/min
Standard Deviation 1.57
|
17.1 breaths/min
Standard Deviation 2.67
|
17.5 breaths/min
Standard Deviation 2.79
|
|
Changes From Baseline in Respiratory Rate During the Treatment Period
Change at Day 22 (n= 6,3,7,33,13)
|
-1.7 breaths/min
Standard Deviation 2.34
|
-1.3 breaths/min
Standard Deviation 2.31
|
-0.7 breaths/min
Standard Deviation 1.03
|
0.3 breaths/min
Standard Deviation 2.1
|
-0.4 breaths/min
Standard Deviation 2.14
|
|
Changes From Baseline in Respiratory Rate During the Treatment Period
Change at Day 43 (n= 6,3,7,32,13)
|
0 breaths/min
Standard Deviation 1.26
|
1.3 breaths/min
Standard Deviation 4.62
|
-0.3 breaths/min
Standard Deviation 0.82
|
0 breaths/min
Standard Deviation 3.08
|
0.7 breaths/min
Standard Deviation 3.5
|
|
Changes From Baseline in Respiratory Rate During the Treatment Period
Change at Day 106 (n= 0,0,0,28,12)
|
NA breaths/min
Standard Deviation NA
Mean Value is not calculated.
|
NA breaths/min
Standard Deviation NA
Mean Value is not calculated.
|
NA breaths/min
Standard Deviation NA
Mean Value is not calculated.
|
-0.8 breaths/min
Standard Deviation 3.54
|
0.5 breaths/min
Standard Deviation 3.27
|
|
Changes From Baseline in Respiratory Rate During the Treatment Period
Change at Day 127 (n= 0,0,0,27,8)
|
NA breaths/min
Standard Deviation NA
Mean Value is not calculated.
|
NA breaths/min
Standard Deviation NA
Mean Value is not calculated.
|
NA breaths/min
Standard Deviation NA
Mean Value is not calculated.
|
0.9 breaths/min
Standard Deviation 3.69
|
0.4 breaths/min
Standard Deviation 1.51
|
|
Changes From Baseline in Respiratory Rate During the Treatment Period
Change at Day 148 (n= 0,0,0,25,7)
|
NA breaths/min
Standard Deviation NA
Mean Value is not calculated.
|
NA breaths/min
Standard Deviation NA
Mean Value is not calculated.
|
NA breaths/min
Standard Deviation NA
Mean Value is not calculated.
|
0.7 breaths/min
Standard Deviation 3.38
|
-0.3 breaths/min
Standard Deviation 1.51
|
PRIMARY outcome
Timeframe: From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)Population: Only participants who received treatment were assessed
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=3 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
n=33 Participants
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
n=13 Participants
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Changes From Baseline in Heart Rate During the Treatment Period
Change at Day 22 (n= 6,3,7,33,13)
|
-0.2 beats per min
Standard Deviation 6.49
|
9.7 beats per min
Standard Deviation 18.72
|
-0.6 beats per min
Standard Deviation 7.76
|
2 beats per min
Standard Deviation 11.39
|
7.2 beats per min
Standard Deviation 12.17
|
|
Changes From Baseline in Heart Rate During the Treatment Period
Change at Day 43 (n= 6,3,7,32,13)
|
-4.3 beats per min
Standard Deviation 9.35
|
18.3 beats per min
Standard Deviation 14.57
|
0.9 beats per min
Standard Deviation 10.32
|
2.8 beats per min
Standard Deviation 11.13
|
4.9 beats per min
Standard Deviation 11.54
|
|
Changes From Baseline in Heart Rate During the Treatment Period
Change at Day 85 (n= 0,0,0,28,13)
|
NA beats per min
Standard Deviation NA
Mean Value is not calculated.
|
NA beats per min
Standard Deviation NA
Mean Value is not calculated.
|
NA beats per min
Standard Deviation NA
Mean Value is not calculated.
|
2.9 beats per min
Standard Deviation 16.17
|
7.2 beats per min
Standard Deviation 10.27
|
|
Changes From Baseline in Heart Rate During the Treatment Period
Change at Day 106 (n= 0,0,0,28,12)
|
NA beats per min
Standard Deviation NA
Mean Value is not calculated.
|
NA beats per min
Standard Deviation NA
Mean Value is not calculated.
|
NA beats per min
Standard Deviation NA
Mean Value is not calculated.
|
0.8 beats per min
Standard Deviation 19.18
|
9.2 beats per min
Standard Deviation 11.67
|
|
Changes From Baseline in Heart Rate During the Treatment Period
Change at Day 127 (n= 0,0,0,27,8)
|
NA beats per min
Standard Deviation NA
Mean Value is not calculated.
|
NA beats per min
Standard Deviation NA
Mean Value is not calculated.
|
NA beats per min
Standard Deviation NA
Mean Value is not calculated.
|
2.2 beats per min
Standard Deviation 13.93
|
7.5 beats per min
Standard Deviation 5.86
|
|
Changes From Baseline in Heart Rate During the Treatment Period
Change at Day 148 (n= 0,0,0,25,7)
|
NA beats per min
Standard Deviation NA
Mean Value is not calculated.
|
NA beats per min
Standard Deviation NA
Mean Value is not calculated.
|
NA beats per min
Standard Deviation NA
Mean Value is not calculated.
|
2.2 beats per min
Standard Deviation 15.88
|
15.3 beats per min
Standard Deviation 14.38
|
|
Changes From Baseline in Heart Rate During the Treatment Period
Change at Day 169 (n= 0,0,0,25,7)
|
NA beats per min
Standard Deviation NA
Mean Value is not calculated.
|
NA beats per min
Standard Deviation NA
Mean Value is not calculated.
|
NA beats per min
Standard Deviation NA
Mean Value is not calculated.
|
3.6 beats per min
Standard Deviation 16.91
|
8 beats per min
Standard Deviation 7.72
|
|
Changes From Baseline in Heart Rate During the Treatment Period
Change at Day 190 (n= 0,0,0,24,6)
|
NA beats per min
Standard Deviation NA
Mean Value is not calculated.
|
NA beats per min
Standard Deviation NA
Mean Value is not calculated.
|
NA beats per min
Standard Deviation NA
Mean Value is not calculated.
|
2.6 beats per min
Standard Deviation 16.01
|
18 beats per min
Standard Deviation 11.31
|
|
Changes From Baseline in Heart Rate During the Treatment Period
Baseline (n= 7,3,7,33,13)
|
88.6 beats per min
Standard Deviation 18.84
|
58 beats per min
Standard Deviation 9.17
|
80 beats per min
Standard Deviation 9.93
|
77.9 beats per min
Standard Deviation 14.18
|
73.3 beats per min
Standard Deviation 12.01
|
|
Changes From Baseline in Heart Rate During the Treatment Period
Change at Day 64 (n= 6,3,6,30,13)
|
0.7 beats per min
Standard Deviation 7.28
|
13 beats per min
Standard Deviation 21.17
|
6.5 beats per min
Standard Deviation 11.47
|
3.4 beats per min
Standard Deviation 14.48
|
5.1 beats per min
Standard Deviation 9.41
|
PRIMARY outcome
Timeframe: From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)Population: Only participants who received treatment were assessed
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=3 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
n=33 Participants
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
n=13 Participants
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Changes From Baseline in Weight During the Treatment Period
Change at Day 106 (n= 0,0,0,28,12)
|
NA kilogram(s)
Standard Deviation NA
Mean Value is not calculated.
|
NA kilogram(s)
Standard Deviation NA
Mean Value is not calculated.
|
NA kilogram(s)
Standard Deviation NA
Mean Value is not calculated.
|
-0.3 kilogram(s)
Standard Deviation 3.53
|
0.4 kilogram(s)
Standard Deviation 3.1
|
|
Changes From Baseline in Weight During the Treatment Period
Change at Day 127 (n= 0,0,0,27,8)
|
NA kilogram(s)
Standard Deviation NA
Mean Value is not calculated.
|
NA kilogram(s)
Standard Deviation NA
Mean Value is not calculated.
|
NA kilogram(s)
Standard Deviation NA
Mean Value is not calculated.
|
-0.1 kilogram(s)
Standard Deviation 4.09
|
2.1 kilogram(s)
Standard Deviation 2.11
|
|
Changes From Baseline in Weight During the Treatment Period
Baseline (n= 7,3,7,33,13)
|
89.3 kilogram(s)
Standard Deviation 13.15
|
81.9 kilogram(s)
Standard Deviation 21.66
|
97.1 kilogram(s)
Standard Deviation 14.29
|
87.7 kilogram(s)
Standard Deviation 14.81
|
92 kilogram(s)
Standard Deviation 22.28
|
|
Changes From Baseline in Weight During the Treatment Period
Change at Day 22 (n= 6,3,7,33,13)
|
-1.8 kilogram(s)
Standard Deviation 1.31
|
-0.3 kilogram(s)
Standard Deviation 1.55
|
-1.4 kilogram(s)
Standard Deviation 2.5
|
-0.4 kilogram(s)
Standard Deviation 1.42
|
-0.2 kilogram(s)
Standard Deviation 1.92
|
|
Changes From Baseline in Weight During the Treatment Period
Change at Day 43 (n= 6,3,7,32,13)
|
-1 kilogram(s)
Standard Deviation 1.95
|
0.2 kilogram(s)
Standard Deviation 2.2
|
-1 kilogram(s)
Standard Deviation 2.99
|
0 kilogram(s)
Standard Deviation 2.2
|
0.5 kilogram(s)
Standard Deviation 1.98
|
|
Changes From Baseline in Weight During the Treatment Period
Change at Day 64 (n= 6,3,6,30,13)
|
0.1 kilogram(s)
Standard Deviation 4.2
|
0.3 kilogram(s)
Standard Deviation 2.04
|
-1.2 kilogram(s)
Standard Deviation 3.08
|
0.2 kilogram(s)
Standard Deviation 2.41
|
0.3 kilogram(s)
Standard Deviation 2.48
|
|
Changes From Baseline in Weight During the Treatment Period
Change at Day 85 (n= 0,0,0,28,13)
|
NA kilogram(s)
Standard Deviation NA
Mean Value is not calculated.
|
NA kilogram(s)
Standard Deviation NA
Mean Value is not calculated.
|
NA kilogram(s)
Standard Deviation NA
Mean Value is not calculated.
|
-0.2 kilogram(s)
Standard Deviation 3.47
|
0.4 kilogram(s)
Standard Deviation 2.87
|
|
Changes From Baseline in Weight During the Treatment Period
Change at Day 148 (n= 0,0,0,25,7)
|
NA kilogram(s)
Standard Deviation NA
Mean Value is not calculated.
|
NA kilogram(s)
Standard Deviation NA
Mean Value is not calculated.
|
NA kilogram(s)
Standard Deviation NA
Mean Value is not calculated.
|
-0.1 kilogram(s)
Standard Deviation 4.45
|
1.9 kilogram(s)
Standard Deviation 2.72
|
|
Changes From Baseline in Weight During the Treatment Period
Change at Day 169 (n= 0,0,0,25,7)
|
NA kilogram(s)
Standard Deviation NA
Mean Value is not calculated.
|
NA kilogram(s)
Standard Deviation NA
Mean Value is not calculated.
|
NA kilogram(s)
Standard Deviation NA
Mean Value is not calculated.
|
-0.1 kilogram(s)
Standard Deviation 4.53
|
1.7 kilogram(s)
Standard Deviation 3.81
|
|
Changes From Baseline in Weight During the Treatment Period
Change at Day 190 (n= 0,0,0,24,6)
|
NA kilogram(s)
Standard Deviation NA
Mean Value is not calculated.
|
NA kilogram(s)
Standard Deviation NA
Mean Value is not calculated.
|
NA kilogram(s)
Standard Deviation NA
Mean Value is not calculated.
|
0.1 kilogram(s)
Standard Deviation 5
|
-0.7 kilogram(s)
Standard Deviation 3.59
|
PRIMARY outcome
Timeframe: From start of study treatment to 6 weeks after study treatment (i.e., maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)Population: Only participants who received treatment were assessed
Any physical examination finding that was classified by the investigator as a clinically significant change (compared with previous examination) was considered an AE, documented on the eCRF, and followed until the outcome was known. The below physical examination findings were recorded and reported. GDASC = General disorders and administration site conditions MND = Metabolism and nutrition disorders SSTD= Skin and subcutaneous tissue disorders MCTD = Musculoskeletal and connective tissue disorders IPPC = Injury, poisoning and procedural complications RTMD = Respiratory, thoracic and mediastinal disorders NBMU = Neoplasms benign, malignant and unspecified (include cysts and polyps) In the below table.
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=3 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=7 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
n=33 Participants
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
n=13 Participants
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Number of Subjects With Physical Examination During the Treatment Period
At day 64: GDASC
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Physical Examination During the Treatment Period
At day 64: MND
|
NA Participants
Data was not collected.
|
NA Participants
Data was not collected.
|
NA Participants
Data was not collected.
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Physical Examination During the Treatment Period
At day 64: SSTD
|
NA Participants
Data was not collected.
|
NA Participants
Data was not collected.
|
NA Participants
Data was not collected.
|
2 Participants
|
6 Participants
|
|
Number of Subjects With Physical Examination During the Treatment Period
At day 190: MCTD
|
NA Participants
The time frame is only applicable to safety cohort.
|
NA Participants
The time frame is only applicable to safety cohort.
|
NA Participants
The time frame is only applicable to safety cohort.
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Physical Examination During the Treatment Period
At day 190: SSTD
|
NA Participants
The time frame is only applicable to safety cohort.
|
NA Participants
The time frame is only applicable to safety cohort.
|
NA Participants
The time frame is only applicable to safety cohort.
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Physical Examination During the Treatment Period
At day 190: Vascular disorders
|
NA Participants
The time frame is only applicable to safety cohort.
|
NA Participants
The time frame is only applicable to safety cohort.
|
NA Participants
The time frame is only applicable to safety cohort.
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Physical Examination During the Treatment Period
At day 190: IPPC
|
NA Participants
The time frame is only applicable to safety cohort.
|
NA Participants
The time frame is only applicable to safety cohort.
|
NA Participants
The time frame is only applicable to safety cohort.
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Physical Examination During the Treatment Period
At day 190: RTMD
|
NA Participants
The time frame is only applicable to safety cohort.
|
NA Participants
The time frame is only applicable to safety cohort.
|
NA Participants
The time frame is only applicable to safety cohort.
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Physical Examination During the Treatment Period
At day 190: NBMU
|
NA Participants
The time frame is only applicable to safety cohort.
|
NA Participants
The time frame is only applicable to safety cohort.
|
NA Participants
The time frame is only applicable to safety cohort.
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Physical Examination During the Treatment Period
At day 190: Social circumstances
|
NA Participants
The time frame is only applicable to safety cohort.
|
NA Participants
The time frame is only applicable to safety cohort.
|
NA Participants
The time frame is only applicable to safety cohort.
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Physical Examination During the Treatment Period
At day 190: GDASC
|
NA Participants
The time frame is only applicable to safety cohort.
|
NA Participants
The time frame is only applicable to safety cohort.
|
NA Participants
The time frame is only applicable to safety cohort.
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Physical Examination During the Treatment Period
At day 190: Gastrointestinal disorders
|
NA Participants
The time frame is only applicable to safety cohort.
|
NA Participants
The time frame is only applicable to safety cohort.
|
NA Participants
The time frame is only applicable to safety cohort.
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From start of study treatment upto 12 monthsPopulation: Only participants who received treatment were assessed
Long-term radiation toxicity included incidence of potential late toxicity, such as new primary cancers and bone marrow changes (acute myelogenous leukemia, myelodysplastic syndrome, and aplastic anemia).
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=33 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=13 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Number of Subjects With Signs of Long-Term Radiation Toxicity
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of study treatment to 6 weeks after study treatment (maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)Population: Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.
Weighted mean area under the curve for the below bone turnover biomarkers were evaluated, ICTP = pyridinoline cross-linked carboxyterminal telopeptide P1NP = N-terminal peptide of procollagen type 1 uCTX-1 = urine C-telopeptide 1
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=32 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=13 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Exploratory Efficacy: Weighted Mean Area Under the Curve for Bone Turnover Biomarkers
uCTX-1
|
14 mcg/L
Standard Deviation 16.86
|
22.6 mcg/L
Standard Deviation 28.2
|
—
|
—
|
—
|
|
Exploratory Efficacy: Weighted Mean Area Under the Curve for Bone Turnover Biomarkers
P1NP
|
42.9 mcg/L
Standard Deviation 42.36
|
106.5 mcg/L
Standard Deviation 118.93
|
—
|
—
|
—
|
|
Exploratory Efficacy: Weighted Mean Area Under the Curve for Bone Turnover Biomarkers
ICTP
|
4.7 mcg/L
Standard Deviation 2.43
|
7 mcg/L
Standard Deviation 7.08
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.
Serum PSA progression defined as two consecutive increases in PSA over a previous reference value within 6 months of first study treatment, each measurement at least 1 week apart.
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=32 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=13 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Exploratory Efficacy: Time to Prostate-specific Antigen (PSA) Progression
|
200 days
Interval 175.0 to 278.0
|
146 days
Interval 86.0 to 169.0
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 85, expanded safety cohortPopulation: Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.
CTCs were measured to follow the evolution of the level of CTCs after treatment.
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=32 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=13 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Exploratory Efficacy: Percent Change From Baseline in Circulating Tumor Cells at Day 85
|
-75.3 Percent Change
Standard Deviation 55.29
|
-68.4 Percent Change
Standard Deviation 61.4
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of study treatment to 12 months, at every 12 weeksPopulation: Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.
Time to first radiologic or clinical progression is determined by one of the following: * For soft tissue lesions, the determination is based on Response Evaluation Criteria in Solid Tumors 1.1. * For bone disease, the determination is based on Prostate Cancer Working Cohort 2 (PCWG2) definitions, which require the appearance of at least 2 new lesions with a confirmatory bone scan at least 6 or more weeks later. For clinical progression, the investigators followed the recommendations of the PCWG25 and used their clinical judgment to determine clinical progression.
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=32 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=13 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Exploratory Efficacy: Time to Clinical or Radiographic Progression
|
365 days
Interval 248.0 to 372.0
|
284 days
Interval 96.0 to 372.0
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of study treatment to 12 months, at every 12 weeksPopulation: Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.
PFS defined as the time from randomization (randomization referred to the date of treatment assignment) to disease progression (radiological or clinical, whichever was earlier) or death (if death occurred before progression was documented). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=32 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=13 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Progression Free Survival (PFS) End Point
|
189 days
Interval 85.0 to 267.0
|
146 days
Interval 86.0 to 169.0
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.
The overall survival (OS) time in days was calculated as number of days since the day of first dose of study medication until the date of death.
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=32 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=13 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Overall Survival Rate
|
89.1 days
Interval 69.8 to 96.4
|
90 days
Interval 47.3 to 98.5
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of study treatment until 12 monthsPopulation: Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.
The subject completed the full BPI (short form) paper questionnaire, and clinical staff completed the analgesic log. The test consists of 10 questions addressing severity, location, chronicity, and amount of relief. In question 3, subjects with pain are asked to evaluate the severity of pain at worst in the past 24 hours in a 0 to 10 scale, with 0 indicating no pain, and 10 indicating the worst pain.
Outcome measures
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=32 Participants
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=13 Participants
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks.
|
|---|---|---|---|---|---|
|
Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain
Day 1
|
23 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain
Day 22
|
24 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain
Day 106
|
20 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain
Day 127
|
19 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain
Day 148
|
18 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain
Day 190
|
17 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain
Safety Follow-up
|
18 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain
6-Month Follow-up
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain
9-Month Follow-up
|
12 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain
12-Month Follow-up
|
7 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain
Day 43
|
22 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain
Day 64
|
21 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain
Day 85
|
20 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain
Day 169
|
17 Participants
|
5 Participants
|
—
|
—
|
—
|
Adverse Events
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
Serious events: 7 serious events
Other events: 33 other events
Deaths: 0 deaths
Docetaxel 75 mg/m^2 - Safety Cohort
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=7 participants at risk
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on National Institute of Standards and Technology (NIST) 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 milligram per square meter (mg/m\^2) every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=3 participants at risk
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=7 participants at risk
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
n=33 participants at risk
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
n=13 participants at risk
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
28.6%
2/7 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
28.6%
2/7 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
1/7 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Ileus
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
General disorders
Chest pain
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Infections and infestations
Skin infection
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Investigations
Biopsy lymph gland
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Nervous system disorders
Spinal cord compression
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Nervous system disorders
Syncope
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Vascular disorders
Embolism
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
Other adverse events
| Measure |
Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation
n=7 participants at risk
Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on National Institute of Standards and Technology (NIST) 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 milligram per square meter (mg/m\^2) every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation
|
Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=3 participants at risk
Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation
n=7 participants at risk
Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
|
Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort
n=33 participants at risk
Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks.
|
Docetaxel 75 mg/m^2 - Safety Cohort
n=13 participants at risk
Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
9.1%
3/33 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.6%
2/7 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
66.7%
2/3 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
71.4%
5/7 • Number of events 5
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
30.3%
10/33 • Number of events 28
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
38.5%
5/13 • Number of events 5
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Cardiac disorders
Palpitations
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Cardiac disorders
Tachycardia
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Eye disorders
Dry eye
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
12.1%
4/33 • Number of events 4
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Eye disorders
Vision blurred
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
33.3%
1/3 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
28.6%
2/7 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
33.3%
11/33 • Number of events 14
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
38.5%
5/13 • Number of events 6
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Diarrhoea
|
71.4%
5/7 • Number of events 5
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
66.7%
2/3 • Number of events 4
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
71.4%
5/7 • Number of events 5
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
42.4%
14/33 • Number of events 36
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
38.5%
5/13 • Number of events 9
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
33.3%
1/3 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
30.8%
4/13 • Number of events 4
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • Number of events 4
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
33.3%
1/3 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
28.6%
2/7 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
48.5%
16/33 • Number of events 33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
61.5%
8/13 • Number of events 13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
33.3%
1/3 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
23.1%
3/13 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
12.1%
4/33 • Number of events 7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
3/7 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
28.6%
2/7 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.2%
5/33 • Number of events 9
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
General disorders
Asthenia
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
24.2%
8/33 • Number of events 24
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
General disorders
Chest discomfort
|
28.6%
2/7 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
General disorders
Chest pain
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
General disorders
Face oedema
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
General disorders
Facial pain
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
General disorders
Fatigue
|
71.4%
5/7 • Number of events 5
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
100.0%
3/3 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
57.1%
4/7 • Number of events 4
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
51.5%
17/33 • Number of events 29
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
69.2%
9/13 • Number of events 15
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
General disorders
Influenza like illness
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
General disorders
Injection site reaction
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
General disorders
Mucosal dryness
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
General disorders
Mucosal inflammation
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.2%
5/33 • Number of events 5
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
General disorders
Oedema
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
12.1%
4/33 • Number of events 7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
General disorders
Oedema peripheral
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
36.4%
12/33 • Number of events 16
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
38.5%
5/13 • Number of events 9
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
General disorders
Pain
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
33.3%
1/3 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
General disorders
Pyrexia
|
14.3%
1/7 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
9.1%
3/33 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
General disorders
Swelling
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Hepatobiliary disorders
Hepatomegaly
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Immune system disorders
Drug hypersensitivity
|
28.6%
2/7 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
33.3%
1/3 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Immune system disorders
Seasonal allergy
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Infections and infestations
Oral infection
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Infections and infestations
Sinusitis
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Infections and infestations
Upper respiratory tract infection
|
28.6%
2/7 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 5
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Injury, poisoning and procedural complications
Radiation proctitis
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Investigations
Blood pressure increased
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Investigations
Respiratory rate increased
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Investigations
Weight decreased
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
33.3%
11/33 • Number of events 13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
30.8%
4/13 • Number of events 6
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
33.3%
1/3 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
21.2%
7/33 • Number of events 9
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
46.2%
6/13 • Number of events 10
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
57.1%
4/7 • Number of events 4
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
33.3%
1/3 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
36.4%
12/33 • Number of events 16
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
30.8%
4/13 • Number of events 5
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
9.1%
3/33 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
33.3%
1/3 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
12.1%
4/33 • Number of events 4
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
9.1%
3/33 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
23.1%
3/13 • Number of events 5
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
42.9%
3/7 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
24.2%
8/33 • Number of events 9
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
28.6%
2/7 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
21.2%
7/33 • Number of events 10
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
61.5%
8/13 • Number of events 12
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Nervous system disorders
Headache
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
23.1%
3/13 • Number of events 5
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Nervous system disorders
Hypoaesthesia
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Nervous system disorders
Myoclonus
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Nervous system disorders
Neuropathy peripheral
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
30.3%
10/33 • Number of events 12
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
30.8%
4/13 • Number of events 5
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Nervous system disorders
Paraesthesia
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
28.6%
2/7 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
100.0%
3/3 • Number of events 4
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
18.2%
6/33 • Number of events 8
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
33.3%
1/3 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Nervous system disorders
Visual field defect
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Psychiatric disorders
Agitation
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Psychiatric disorders
Confusional state
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
9.1%
3/33 • Number of events 4
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Renal and urinary disorders
Haematuria
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Renal and urinary disorders
Nocturia
|
14.3%
1/7 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Renal and urinary disorders
Pollakiuria
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
33.3%
1/3 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.2%
5/33 • Number of events 6
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Renal and urinary disorders
Urinary incontinence
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Reproductive system and breast disorders
Priapism
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
12.1%
4/33 • Number of events 5
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
23.1%
3/13 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
33.3%
1/3 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
42.9%
3/7 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
33.3%
1/3 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
42.9%
3/7 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
38.5%
5/13 • Number of events 5
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
33.3%
1/3 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
23.1%
3/13 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
23.1%
3/13 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
33.3%
1/3 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
42.9%
3/7 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
36.4%
12/33 • Number of events 12
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
53.8%
7/13 • Number of events 7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
28.6%
2/7 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
23.1%
3/13 • Number of events 4
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
9.1%
3/33 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
9.1%
3/33 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Nail bed disorder
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
23.1%
3/13 • Number of events 3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.2%
5/33 • Number of events 5
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.2%
5/33 • Number of events 5
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
33.3%
1/3 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
15.4%
2/13 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Vascular disorders
Flushing
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
6.1%
2/33 • Number of events 2
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Vascular disorders
Hot flush
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
3.0%
1/33 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
14.3%
1/7 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/13
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
|
Vascular disorders
Vascular pain
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/3
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/7
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
0.00%
0/33
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
7.7%
1/13 • Number of events 1
Number of participants at risk are from safety analysis set, please refer to participant flow section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60