Trial Outcomes & Findings for Study of NGR-hTNF in Combination With Doxorubicin in Solid Tumors (NCT NCT00305084)
NCT ID: NCT00305084
Last Updated: 2019-10-04
Results Overview
An Adverse Event (AE) is any untoward medical occurrence or experience in a patient or clinical investigation subject treated administered a pharmaceutical product and which does not necessarily have to have a casual relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Through study completion, an average of 1 year
Results posted on
2019-10-04
Participant Flow
Study Period: 28 February 2006 (first enrollment); 8 May 2007 (last completed). 3 investigational centres in Italy and 1 in Netherlands.
Screening details: Planned sample size: 20-25 patients; Patients screened n.: 15; Patients screening failure n.: 0.
Participant milestones
| Measure |
Cohort 1: NGR-hTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 60 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 2: NGR-hTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 3: NGR-hTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2
NGR-hTNF: 0.4 μg/m\^2 as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2
NGR-hTNF: 0.8 μg/m\^2 as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 5: NGR-hTNF 1.6 μg/m^2+ Doxorubicin 75 mg/m^2
NGR-hTNF: 1.6 μg/m\^2 as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of NGR-hTNF in Combination With Doxorubicin in Solid Tumors
Baseline characteristics by cohort
| Measure |
Cohort 1: NGRhTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 60 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 2: NGRhTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 3: NGRhTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.4 μg/m\^2as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 4: NGRhTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.8 μg/m\^2as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 5: NGRhTNF 1.6 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 1.6 μg/m\^2as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=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, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Region of Enrollment
Netherlands
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
5 participants
n=10 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
10 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearAn Adverse Event (AE) is any untoward medical occurrence or experience in a patient or clinical investigation subject treated administered a pharmaceutical product and which does not necessarily have to have a casual relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Cohort 1: NGRhTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 60 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 2: NGRhTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 3: NGR-hTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.4 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin:75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.8 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 5:NGR-hTNF 1.6 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 1.6 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
|---|---|---|---|---|---|
|
Number of Adverse Events From Escalating Doses of NGR-hTNF in Combination With a Fixed Dose of Doxorubicin
|
59 Adverse event
|
142 Adverse event
|
67 Adverse event
|
101 Adverse event
|
124 Adverse event
|
SECONDARY outcome
Timeframe: prior to infusion and 15', 30', 60', 90', 120', 134' [1 minute before the end of doxorubicin administration], 180', 240', 360' minutesPopulation: Pharmacokinetic of NGR-hTNF was conducted in 5 sequential cohorts of patients, 3 patients per each cohort were planned). All the patients treated on Cycle 1 were still in the study on Cycle2. On Cycle3 twelve out of fifteen patients were still in the study. Subjects no more included in the study were 1 patient in cohort 1 and 2 patients in cohort 5
Pharmacokinetic profiles of NGR-hTNF and doxorubicin was conducted in 4 sequential cohorts of patients (Three patients per each cohort were planned). The first 3 patients of the first cohort were treated with 0.2 μg/m2 of NGR-hTNF in combination with a suboptimal dose (minus 20%) of doxorubicin (60 mg/m2).Following 4 cohorts were treated with escalating dose of NGR-hTNF (0.2, 0.4, 0.8 and 1.6 μg/m2) in combination with a standard dose of doxorubicin (75 mg/m2):
Outcome measures
| Measure |
Cohort 1: NGRhTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 60 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 2: NGRhTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 3: NGR-hTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.4 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin:75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.8 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 5:NGR-hTNF 1.6 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 1.6 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
|---|---|---|---|---|---|
|
Pharmacokinetic Profiles of NGR-hTNF Administrated in Combination With Doxorubicin (Cmax)
Cycle1_Cmax NGR-hTNF
|
2.22 pg/mL
Standard Deviation 0.58
|
1.82 pg/mL
Standard Deviation 0.90
|
4.44 pg/mL
Standard Deviation 1.70
|
8.10 pg/mL
Standard Deviation 1.50
|
15.7 pg/mL
Standard Deviation 8.34
|
|
Pharmacokinetic Profiles of NGR-hTNF Administrated in Combination With Doxorubicin (Cmax)
Cycle2_Cmax NGR-hTNF
|
3.10 pg/mL
Standard Deviation 1.54
|
2.31 pg/mL
Standard Deviation 1.69
|
2.74 pg/mL
Standard Deviation 2.94
|
18.0 pg/mL
Standard Deviation 15.6
|
34.4 pg/mL
Standard Deviation 22.5
|
|
Pharmacokinetic Profiles of NGR-hTNF Administrated in Combination With Doxorubicin (Cmax)
Cycle3_Cmax NGR-hTNF
|
2.28 pg/mL
Standard Deviation 0.21
|
3.04 pg/mL
Standard Deviation 2.14
|
8.91 pg/mL
Standard Deviation 8.70
|
11.2 pg/mL
Standard Deviation 5.90
|
25.4 pg/mL
|
SECONDARY outcome
Timeframe: prior to infusion and 15', 30', 60', 90', 120', 134' [1 minute before the end of doxorubicin administration], 180', 240', 360' minutesPopulation: Pharmacokinetic of NGR-hTNF was conducted in 5 sequential cohorts of patients, 3 patients per each cohort were planned). All the patients treated on Cycle 1 were still in the study on Cycle2. On Cycle3 twelve out of fifteen patients were still in the study. Subjects no more included in the study were 1 patient in cohort 1 and 2 patients in cohort 5
Pharmacokinetic profiles of NGR-hTNF and doxorubicin was conducted in 4 sequential cohorts of patients (Three patients per each cohort were planned). The first 3 patients of the first cohort were treated with 0.2 μg/m2 of NGR-hTNF in combination with a suboptimal dose (minus 20%) of doxorubicin (60 mg/m2).Following 4 cohorts were treated with escalating dose of NGR-hTNF (0.2, 0.4, 0.8 and 1.6 μg/m2) in combination with a standard dose of doxorubicin (75 mg/m2):
Outcome measures
| Measure |
Cohort 1: NGRhTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 60 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 2: NGRhTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 3: NGR-hTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.4 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin:75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.8 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 5:NGR-hTNF 1.6 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 1.6 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
|---|---|---|---|---|---|
|
Pharmacokinetic Profiles of NGR-hTNF Administrated in Combination With Doxorubicin (Tmax)
Cycle1_tmax_NGR-hTNF
|
0.25 h
Standard Deviation 0.00
|
2.50 h
Standard Deviation 3.04
|
2.50 h
Standard Deviation 3.04
|
0.78 h
Standard Deviation 0.39
|
2.83 h
Standard Deviation 3.18
|
|
Pharmacokinetic Profiles of NGR-hTNF Administrated in Combination With Doxorubicin (Tmax)
Cycle2_tmax NGR-hTNF
|
0.87 h
Standard Deviation 0.29
|
2.42 h
Standard Deviation 3.13
|
1.03 h
Standard Deviation 0.46
|
0.75 h
Standard Deviation 0.35
|
0.83 h
Standard Deviation 0.29
|
|
Pharmacokinetic Profiles of NGR-hTNF Administrated in Combination With Doxorubicin (Tmax)
Cycle3_tmax NGR-hTNF
|
1.04 h
Standard Deviation 0.057
|
4.08 h
Standard Deviation 3.32
|
0.83 h
Standard Deviation 0.29
|
0.67 h
Standard Deviation 0.29
|
6.00 h
|
SECONDARY outcome
Timeframe: prior to infusion and 15', 30', 60', 90', 120', 134' [1 minute before the end of doxorubicin administration], 180', 240', 360' minutesPopulation: Pharmacokinetic of NGR-hTNF was conducted in 5 sequential cohorts of patients, 3 patients per each cohort were planned). All the patients treated on Cycle 1 were still in the study on Cycle2. On Cycle3 twelve out of fifteen patients were still in the study. Subjects no more included in the study were 1 patient in cohort 1 and 2 patients in cohort 5
Pharmacokinetic profiles of NGR-hTNF and doxorubicin was conducted in 4 sequential cohorts of patients (Three patients per each cohort were planned). The first 3 patients of the first cohort were treated with 0.2 μg/m2 of NGR-hTNF in combination with a suboptimal dose (minus 20%) of doxorubicin (60 mg/m2).Following 4 cohorts were treated with escalating dose of NGR-hTNF (0.2, 0.4, 0.8 and 1.6 μg/m2) in combination with a standard dose of doxorubicin (75 mg/m2):
Outcome measures
| Measure |
Cohort 1: NGRhTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 60 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 2: NGRhTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 3: NGR-hTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.4 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin:75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.8 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 5:NGR-hTNF 1.6 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 1.6 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
|---|---|---|---|---|---|
|
Pharmacokinetic Profiles of NGR-hTNF Administrated in Combination With Doxorubicin (AUC0-t(Last))
Cycle1_AUC0-t(last)_NGR-hTNF
|
1.94 pg⋅h/mL
Standard Deviation 0.27
|
1.99 pg⋅h/mL
Standard Deviation 1.42
|
11.8 pg⋅h/mL
Standard Deviation 4.13
|
12.0 pg⋅h/mL
Standard Deviation 0.70
|
25.7 pg⋅h/mL
Standard Deviation 19.4
|
|
Pharmacokinetic Profiles of NGR-hTNF Administrated in Combination With Doxorubicin (AUC0-t(Last))
Cycle2_AUC0-t(last)_ NGR-hTNF
|
7.84 pg⋅h/mL
Standard Deviation 7.06
|
2.74 pg⋅h/mL
Standard Deviation 1.63
|
4.53 pg⋅h/mL
Standard Deviation 5.95
|
20.5 pg⋅h/mL
Standard Deviation 13.0
|
46.4 pg⋅h/mL
Standard Deviation 28.9
|
|
Pharmacokinetic Profiles of NGR-hTNF Administrated in Combination With Doxorubicin (AUC0-t(Last))
Cycle3_AUC0-t(last)_NGR-hTNF
|
4.35 pg⋅h/mL
Standard Deviation 0.40
|
2.71 pg⋅h/mL
Standard Deviation 1.11
|
10.6 pg⋅h/mL
Standard Deviation 7.13
|
18.2 pg⋅h/mL
Standard Deviation 7.49
|
64.0 pg⋅h/mL
|
SECONDARY outcome
Timeframe: prior to infusion and 15', 30', 60', 90', 120', 134' [1 minute before the end of doxorubicin administration], 180', 240', 360' minutesPopulation: Pharmacodynamic of NGR-hTNF was conducted in 5 sequential cohorts of patients, 3 patients per each cohort were planned). All the patients treated on Cycle 1 were still in the study on Cycle2. On Cycle3 twelve out of fifteen patients were still in the study. Subjects no more included in the study were 1 patient in cohort 1 and 2 patients in cohort 5
Pharmacodynamic calculations for sTNF-R1 and sTNF-R2 were performed on the plasma concentrations from which the baseline concentrations were subtracted (i.e. on positive and negative values). At all doses, Emax, i.e. the maximal stimulatory effect, and tmax were estimated as the coordinates of the highest point of the plasma profile (y, x axis, respectively)
Outcome measures
| Measure |
Cohort 1: NGRhTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 60 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 2: NGRhTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 3: NGR-hTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.4 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin:75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.8 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 5:NGR-hTNF 1.6 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 1.6 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
|---|---|---|---|---|---|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Emax)
Cycle 1_Emax sTNF-R1
|
0.34 ng/mL
Standard Deviation 0.08
|
-0.19 ng/mL
Standard Deviation 0.60
|
0.21 ng/mL
Standard Deviation 0.26
|
0.59 ng/mL
Standard Deviation 0.46
|
1.64 ng/mL
Standard Deviation 0.69
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Emax)
Cycle 1_Emax sTNF-R2
|
0.01 ng/mL
Standard Deviation 0.07
|
0.26 ng/mL
Standard Deviation 0.10
|
0.13 ng/mL
Standard Deviation 0.14
|
0.56 ng/mL
Standard Deviation 0.40
|
2.23 ng/mL
Standard Deviation 0.80
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Emax)
Cycle 2_Emax sTNF-R1
|
0.49 ng/mL
Standard Deviation 0.11
|
0.21 ng/mL
Standard Deviation 0.31
|
0.45 ng/mL
Standard Deviation 0.33
|
0.69 ng/mL
Standard Deviation 0.46
|
1.21 ng/mL
Standard Deviation 0.80
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Emax)
Cycle 2_Emax sTNF-R2
|
0.31 ng/mL
Standard Deviation 0.40
|
-0.12 ng/mL
Standard Deviation 0.25
|
0.33 ng/mL
Standard Deviation 0.21
|
1.31 ng/mL
Standard Deviation 0.79
|
2.62 ng/mL
Standard Deviation 1.64
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Emax)
Cycle 3_Emax sTNF-R1
|
0.44 ng/mL
Standard Deviation 0.13
|
0.51 ng/mL
Standard Deviation 0.48
|
0.38 ng/mL
Standard Deviation 0.13
|
0.84 ng/mL
Standard Deviation 0.11
|
0.88 ng/mL
Standard Deviation 1
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Emax)
Cycle 3_Emax sTNF-R2
|
0.11 ng/mL
Standard Deviation 0.04
|
-0.13 ng/mL
Standard Deviation 0.12
|
0.37 ng/mL
Standard Deviation 0.17
|
1.10 ng/mL
Standard Deviation 0.24
|
1.44 ng/mL
Standard Deviation 1
|
SECONDARY outcome
Timeframe: prior to infusion and 15', 30', 60', 90', 120', 134' [1 minute before the end of doxorubicin administration], 180', 240', 360' minutesPopulation: Pharmacodynamic of NGR-hTNF was conducted in 5 sequential cohorts of patients, 3 patients per each cohort were planned). All the patients treated on Cycle 1 were still in the study on Cycle2. On Cycle3 twelve out of fifteen patients were still in the study. Subjects no more included in the study were 1 patient in cohort 1 and 2 patients in cohort 5
Pharmacodynamic calculations for sTNF-R1 and sTNF-R2 were performed on the plasma concentrations from which the baseline concentrations were subtracted (i.e. on positive and negative values). At all doses, Emax, i.e. the maximal stimulatory effect, and tmax were estimated as the coordinates of the highest point of the plasma profile (y, x axis, respectively)
Outcome measures
| Measure |
Cohort 1: NGRhTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 60 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 2: NGRhTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 3: NGR-hTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.4 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin:75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.8 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 5:NGR-hTNF 1.6 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 1.6 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
|---|---|---|---|---|---|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Tmax)
Cycle 2_Tmax sTNF-R1
|
4.71 h
Standard Deviation 1.25
|
6.00 h
Standard Deviation 0.00
|
4.33 h
Standard Deviation 2.89
|
4.12 h
Standard Deviation 2.67
|
1.17 h
Standard Deviation 0.29
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Tmax)
Cycle 1_Tmax sTNF-R1
|
5.47 h
Standard Deviation 1.17
|
2.17 h
Standard Deviation 3.32
|
4.33 h
Standard Deviation 2.89
|
3.78 h
Standard Deviation 3.15
|
2.83 h
Standard Deviation 3.18
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Tmax)
Cycle 1_Tmax sTNF-R2
|
3.19 h
Standard Deviation 3.00
|
0.25 h
Standard Deviation 0.00
|
3.67 h
Standard Deviation 2.52
|
1.78 h
Standard Deviation 0.32
|
2.83 h
Standard Deviation 3.18
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Tmax)
Cycle 2_Tmax sTNF-R2
|
4.71 h
Standard Deviation 1.25
|
1.42 h
Standard Deviation 1.42
|
3.67 h
Standard Deviation 2.52
|
1.50 h
Standard Deviation 0.71
|
1.17 h
Standard Deviation 0.29
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Tmax)
Cycle 3_Tmax sTNF-R1
|
6.09 h
Standard Deviation 0.12
|
2.33 h
Standard Deviation 3.18
|
5.33 h
Standard Deviation 1.16
|
1.84 h
Standard Deviation 1.04
|
6.00 h
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Tmax)
Cycle 3_Tmax sTNF-R2
|
6.09 h
Standard Deviation 0.12
|
2.33 h
Standard Deviation 3.18
|
3.50 h
Standard Deviation 2.78
|
1.18 h
Standard Deviation 0.31
|
1.00 h
|
SECONDARY outcome
Timeframe: prior to infusion and 15', 30', 60', 90', 120', 134' [1 minute before the end of doxorubicin administration], 180', 240', 360' minutesPopulation: Pharmacodynamic of NGR-hTNF was conducted in 5 sequential cohorts of patients, 3 patients per each cohort were planned). All the patients treated on Cycle 1 were still in the study on Cycle2. On Cycle3 twelve out of fifteen patients were still in the study. Subjects no more included in the study were 1 patient in cohort 1 and 2 patients in cohort 5
Pharmacodynamic calculations for sTNF-R1 and sTNF-R2 were performed on the plasma concentrations from which the baseline concentrations were subtracted (i.e. on positive and negative values). At all doses, Emax, i.e. the maximal stimulatory effect, and tmax were estimated as the coordinates of the highest point of the plasma profile (y, x axis, respectively)
Outcome measures
| Measure |
Cohort 1: NGRhTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 60 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 2: NGRhTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 3: NGR-hTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.4 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin:75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.8 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 5:NGR-hTNF 1.6 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 1.6 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
|---|---|---|---|---|---|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (ARC)
Cycle 1_ARC sTNF-R1
|
0.1 ng⋅h/mL
Standard Deviation 0.24
|
-3.52 ng⋅h/mL
Standard Deviation 3.71
|
-0.64 ng⋅h/mL
Standard Deviation 0.86
|
2.11 ng⋅h/mL
Standard Deviation 1.72
|
3.38 ng⋅h/mL
Standard Deviation 0.81
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (ARC)
Cycle 1_ARC sTNF-R2
|
-1.04 ng⋅h/mL
Standard Deviation 1.12
|
-1.58 ng⋅h/mL
Standard Deviation 1.17
|
-1.36 ng⋅h/mL
Standard Deviation 2.22
|
2.10 ng⋅h/mL
Standard Deviation 1.41
|
6.08 ng⋅h/mL
Standard Deviation 3.40
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (ARC)
Cycle 2_ARC sTNF-R1
|
0.75 ng⋅h/mL
Standard Deviation 0.27
|
-0.57 ng⋅h/mL
Standard Deviation 0.58
|
0.74 ng⋅h/mL
Standard Deviation 1.38
|
1.76 ng⋅h/mL
Standard Deviation 1.01
|
3.38 ng⋅h/mL
Standard Deviation 2.85
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (ARC)
Cycle 2_ARC sTNF-R2
|
0.35 ng⋅h/mL
Standard Deviation 1.16
|
-2.89 ng⋅h/mL
Standard Deviation 0.28
|
0.28 ng⋅h/mL
Standard Deviation 1.03
|
2.95 ng⋅h/mL
Standard Deviation 0.04
|
9.08 ng⋅h/mL
Standard Deviation 7.17
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (ARC)
Cycle 3_ARC sTNF-R1
|
0.32 ng⋅h/mL
Standard Deviation 0.29
|
0.11 ng⋅h/mL
Standard Deviation 1.56
|
0.85 ng⋅h/mL
Standard Deviation 0.37
|
2.49 ng⋅h/mL
Standard Deviation 0.66
|
2.55 ng⋅h/mL
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (ARC)
Cycle 3_ARC sTNF-R2
|
-1.08 ng⋅h/mL
Standard Deviation 0.09
|
-3.30 ng⋅h/mL
Standard Deviation 2.06
|
0.61 ng⋅h/mL
Standard Deviation 0.34
|
3.25 ng⋅h/mL
Standard Deviation 1.00
|
5.58 ng⋅h/mL
|
SECONDARY outcome
Timeframe: prior to infusion and 15', 30', 60', 90', 120', 134' [1 minute before the end of doxorubicin administration], 180', 240', 360' minutesPopulation: Pharmacodynamic of NGR-hTNF was conducted in 5 sequential cohorts of patients, 3 patients per each cohort were planned). All the patients treated on Cycle 1 were still in the study on Cycle2. On Cycle3 twelve out of fifteen patients were still in the study. Subjects no more included in the study were 1 patient in cohort 1 and 2 patients in cohort 5
Pharmacodynamic calculations for sTNF-R1 and sTNF-R2 were performed on the plasma concentrations from which the baseline concentrations were subtracted (i.e. on positive and negative values). At all doses, Emax, i.e. the maximal stimulatory effect, and tmax were estimated as the coordinates of the highest point of the plasma profile (y, x axis, respectively)
Outcome measures
| Measure |
Cohort 1: NGRhTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 60 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 2: NGRhTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 3: NGR-hTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.4 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin:75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.8 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 5:NGR-hTNF 1.6 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 1.6 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
|---|---|---|---|---|---|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Eav)
Cycle 3_Eav sTNF-R2
|
-0.18 ng/mL
Standard Deviation 0.02
|
-0.55 ng/mL
Standard Deviation 0.34
|
0.10 ng/mL
Standard Deviation 0.06
|
0.54 ng/mL
Standard Deviation 0.17
|
0.93 ng/mL
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Eav)
Cycle 1_Eav sTNF-R1
|
0.02 ng/mL
Standard Deviation 0.04
|
-0.59 ng/mL
Standard Deviation 0.62
|
-0.11 ng/mL
Standard Deviation 0.14
|
0.35 ng/mL
Standard Deviation 0.29
|
0.56 ng/mL
Standard Deviation 0.14
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Eav)
Cycle 1_Eav sTNF-R2
|
-0.17 ng/mL
Standard Deviation 0.19
|
-0.26 ng/mL
Standard Deviation 0.20
|
-0.23 ng/mL
Standard Deviation 0.37
|
0.35 ng/mL
Standard Deviation 0.24
|
1.01 ng/mL
Standard Deviation 0.57
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Eav)
Cycle 2_Eav sTNF-R1
|
0.13 ng/mL
Standard Deviation 0.05
|
-0.10 ng/mL
Standard Deviation 0.10
|
0.12 ng/mL
Standard Deviation 0.23
|
0.29 ng/mL
Standard Deviation 0.17
|
0.56 ng/mL
Standard Deviation 0.48
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Eav)
Cycle 2_Eav sTNF-R2
|
0.06 ng/mL
Standard Deviation 0.19
|
-0.48 ng/mL
Standard Deviation 0.05
|
0.003 ng/mL
Standard Deviation 0.17
|
0.49 ng/mL
Standard Deviation 0.01
|
1.51 ng/mL
Standard Deviation 1.20
|
|
sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Eav)
Cycle 3_Eav sTNF-R1
|
0.05 ng/mL
Standard Deviation 0.05
|
0.02 ng/mL
Standard Deviation 0.26
|
0.14 ng/mL
Standard Deviation 0.06
|
0.42 ng/mL
Standard Deviation 0.11
|
0.43 ng/mL
|
SECONDARY outcome
Timeframe: during the studyPopulation: No analysis was performed. No biopsy was preformed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after the first 2 cycles(Follow-up 2) of treatment and then every 2 cycles (Follow-up 4,6..). In case of detection of a complete or partial response, a confirmation assessment must be performed ≥ 4 weeks after the first documentation of the response.Population: disease progression or until the start of another treatment
Response to treatment was assessed on a set of target lesions(TL) chosen before the 1st treatment administration, the list of TL must be reported on the initial measurement form before the start of treatment. Lesions had to have clearly defined borders and initially were measured in at least one dimension, and had to be repeated at each evaluation of the disease by the same method. Sum of the longest diameter (LD) was calculated as the baseline sum LD Complete Response(CR): Disappearance of all TL Partial Response(PR): At least a 30% decrease in the sum of the LD of TL, taking as reference the base line sum LD Progressive Disease(PD): At least a 20% increase in the sum of LD of TL, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Outcome measures
| Measure |
Cohort 1: NGRhTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 60 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 2: NGRhTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 3: NGR-hTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.4 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin:75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 0.8 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 5:NGR-hTNF 1.6 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 Participants
NGR-hTNF: 1.6 μg/m\^2 as 60-minute intravenous infusion every 3 weeks Doxorubicin: 75 mg/m\^2 intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
|---|---|---|---|---|---|
|
Signs of Anticancer Activity by Standard Imaging or Clinically; When Possible Tumor Response Will be Documented According to RECIST Criteria
N. of Stable Disease_follow-up 2
|
2 participants
|
3 participants
|
3 participants
|
2 participants
|
3 participants
|
|
Signs of Anticancer Activity by Standard Imaging or Clinically; When Possible Tumor Response Will be Documented According to RECIST Criteria
N. of Progression Disease_follow-up 2
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Signs of Anticancer Activity by Standard Imaging or Clinically; When Possible Tumor Response Will be Documented According to RECIST Criteria
N. of Partial Response follow-up 2
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Signs of Anticancer Activity by Standard Imaging or Clinically; When Possible Tumor Response Will be Documented According to RECIST Criteria
N. of Stable Disease_follow-up 4
|
1 participants
|
2 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Signs of Anticancer Activity by Standard Imaging or Clinically; When Possible Tumor Response Will be Documented According to RECIST Criteria
N. of Progression Disease_follow-up 4
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Signs of Anticancer Activity by Standard Imaging or Clinically; When Possible Tumor Response Will be Documented According to RECIST Criteria
N. of Partial Response follow-up 4
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Signs of Anticancer Activity by Standard Imaging or Clinically; When Possible Tumor Response Will be Documented According to RECIST Criteria
N. of Stable Disease_follow-up 6
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Signs of Anticancer Activity by Standard Imaging or Clinically; When Possible Tumor Response Will be Documented According to RECIST Criteria
N. of Progression Disease_follow-up 6
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Signs of Anticancer Activity by Standard Imaging or Clinically; When Possible Tumor Response Will be Documented According to RECIST Criteria
N. of Partial Response follow-up 6
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Signs of Anticancer Activity by Standard Imaging or Clinically; When Possible Tumor Response Will be Documented According to RECIST Criteria
N. of Stable Disease_follow-up 8
|
—
|
1 participants
|
—
|
1 participants
|
—
|
|
Signs of Anticancer Activity by Standard Imaging or Clinically; When Possible Tumor Response Will be Documented According to RECIST Criteria
N. of Progression Disease_follow-up 8
|
—
|
1 participants
|
—
|
2 participants
|
—
|
|
Signs of Anticancer Activity by Standard Imaging or Clinically; When Possible Tumor Response Will be Documented According to RECIST Criteria
N. of Partial Response follow-up 8
|
—
|
0 participants
|
—
|
0 participants
|
—
|
Adverse Events
Cohort 1: NGRhTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort 2: NGRhTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 3: NGR-hTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 5: NGR-hTNF: 1.6 μg/m^2 + Doxorubicin 75 mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort 1: NGRhTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2
n=3 participants at risk
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 60 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 2: NGRhTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 participants at risk
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 3: NGR-hTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 participants at risk
NGR-hTNF: 0.4 μg/m\^2 as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 participants at risk
NGR-hTNF: 0.8 μg/m\^2 as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 5: NGR-hTNF: 1.6 μg/m^2 + Doxorubicin 75 mg/m^2
n=3 participants at risk
NGR-hTNF: 1.6 μg/m\^2 as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
|---|---|---|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
Other adverse events
| Measure |
Cohort 1: NGRhTNF 0.2 μg/m^2+ Doxorubicin 60 mg/m^2
n=3 participants at risk
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 60 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 2: NGRhTNF 0.2 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 participants at risk
NGR-hTNF: 0.2 μg/m\^2 as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 3: NGR-hTNF 0.4 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 participants at risk
NGR-hTNF: 0.4 μg/m\^2 as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 4: NGR-hTNF 0.8 μg/m^2+ Doxorubicin 75 mg/m^2
n=3 participants at risk
NGR-hTNF: 0.8 μg/m\^2 as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
Cohort 5: NGR-hTNF: 1.6 μg/m^2 + Doxorubicin 75 mg/m^2
n=3 participants at risk
NGR-hTNF: 1.6 μg/m\^2 as 60-minute intravenous infusion every 3 weeks
Doxorubicin: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 5 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 4 • Through study completion, an average of 1 year
|
100.0%
3/3 • Number of events 10 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 10 • Through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 9 • Through study completion, an average of 1 year
|
100.0%
3/3 • Number of events 12 • Through study completion, an average of 1 year
|
100.0%
3/3 • Number of events 14 • Through study completion, an average of 1 year
|
100.0%
3/3 • Number of events 10 • Through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Through study completion, an average of 1 year
|
100.0%
3/3 • Number of events 3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 16 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3 • Number of events 5 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 8 • Through study completion, an average of 1 year
|
100.0%
3/3 • Number of events 12 • Through study completion, an average of 1 year
|
100.0%
3/3 • Number of events 18 • Through study completion, an average of 1 year
|
100.0%
3/3 • Number of events 10 • Through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 4 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Cardiac disorders
Asystole
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 2 • Through study completion, an average of 1 year
|
|
Cardiac disorders
Mitral valve sclerosis
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 2 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Eye disorders
Dry eyes
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Eye disorders
Keratitis
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 2 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 8 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 4 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Aptyalism
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 7 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 2 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Faeces discoloured
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Gastritis
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 12 • Through study completion, an average of 1 year
|
100.0%
3/3 • Number of events 9 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 5 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 4 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Oesophagitis
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Pruritus ani
|
33.3%
1/3 • Number of events 3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Through study completion, an average of 1 year
|
100.0%
3/3 • Number of events 3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Teething
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Number of events 3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 2 • Through study completion, an average of 1 year
|
100.0%
3/3 • Number of events 7 • Through study completion, an average of 1 year
|
|
General disorders
Asthenia
|
100.0%
3/3 • Number of events 3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
General disorders
Chest pain
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 4 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 6 • Through study completion, an average of 1 year
|
100.0%
3/3 • Number of events 5 • Through study completion, an average of 1 year
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 5 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 4 • Through study completion, an average of 1 year
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 4 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 7 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 6 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 5 • Through study completion, an average of 1 year
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Infections and infestations
Escherichia infection
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Infections and infestations
Mycosis fungoides
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Infections and infestations
Onychomycosis
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Injury, poisoning and procedural complications
Graft complication
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Injury, poisoning and procedural complications
Post procedural pain
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 3 • Through study completion, an average of 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 7 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
|
Investigations
Troponin I
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 2 • Through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 6 • Through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in limb
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
33.3%
1/3 • Number of events 3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Sciatica
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Shoulder blade pain
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Nervous system disorders
Burning sensation
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Nervous system disorders
Loss of consciousness
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Nervous system disorders
Muscle tone abnormal
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
|
Nervous system disorders
Neuropathic pain
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Nervous system disorders
Paraesthesia
|
66.7%
2/3 • Number of events 2 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 3 • Through study completion, an average of 1 year
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Through study completion, an average of 1 year
|
100.0%
3/3 • Number of events 4 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 2 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal disorder
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
66.7%
2/3 • Number of events 2 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
66.7%
2/3 • Number of events 5 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Peely skin
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Red face
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 14 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Vascular disorders
Haematoma
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Vascular disorders
Haemorrhoids
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Vascular disorders
Head cold
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Vascular disorders
Renal vein thrombosis
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Vascular disorders
Restless legs syndrome
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Vascular disorders
Shock
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 2 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/3 • Through study completion, an average of 1 year
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
0.00%
0/3 • Through study completion, an average of 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place