Trial Outcomes & Findings for A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6 (NCT NCT03058289)
NCT ID: NCT03058289
Last Updated: 2025-02-27
Results Overview
The primary objective is to assess the safety and tolerability of single and multiple intratumoral doses of INT230-6 in subjects with advanced or recurrent malignancies. This will be assessed by the rate of ≥ grade 3 AE's attributed to INT230-6 and not the underlying disease. NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 (least severe) to 5 (most severe)) All recorded adverse events will be listed and tabulated by system organ class, preferred term, and dose and coded according to the most current version of MedDRA. The incidence of adverse events will be tabulated and reviewed for potential significance and clinical importance. Adverse Events will be summarized for all reported data and by study period: a) up to and including 28 days post last dose of initial treatment, and b) from first dose of re-initiation of treatment, for subjects who re-initiate study therapy while in follow-up, up to 28 days post-dose of the last re-treatment dose.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
111 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2025-02-27
Participant Flow
One Subject (IT-004-016) had been enrolled in the study but deteriorated before the first dose was administered. The subject was originally planned to be placed in Cohort DEC2. This discontinuation means 110 patients were treated.
Participant milestones
| Measure |
Monotherapy: Cohort A1
A1:INT230-6 injections every 28 days for 5 sessions into only superficial tumors, low starting dose, low concentration per tumor.
|
Monotherapy: Cohort B1
B1:INT230-6 injections every 28 days for 5 sessions into deep tumors, low starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EA
EA:INT230-6 injections every 2 weeks for 5 sessions into superficial tumors, medium starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EC
EC:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, moderately high starting dose, high drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EC-2
EC2:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, high starting dose, moderate drug concentration per tumor, higher number of tumors to be treated per session than EC.
|
Monotherapy: Cohort EC3
EC3:INT230-6 injections every 2 weeks for 5 sessions at fixed maximal dose into superficial or deep tumors, unlimited number of tumors to be treated per session with retreatment once every 9 weeks for two years. Completed Cohort "
|
INT 230-6 Combined With Pembrolizumab (Cohort DEC)
DEC: INT230-6 injections every 2 weeks for 5 sessions with the possibility for INT230-6 retreatment into superficial tumors, with addition of anti-PD-1 antibody Keytruda (pembrolizumab) dosed concurrently starting at Day 1 every 3 weeks for two years for selected cancer types.
|
INT 230-6 Combined With Pembrolizumab (Cohort DEC2)
DEC2:INT230-6 per the dosing of cohort EC3 combined with Keytruda (pembrolizumab) dosed per DEC concurrently starting at Day 1 for selected cancers.
|
INT 230-6 Combined With Ipilimumab (Cohort FEC)
FEC: INT230-6 per the EC3 regimen combined with Yervoy (ipilimumab) dosed concurrently starting at Day 1 every 3 weeks for four treatments for selected cancer types.
Completed Cohort
anti-CTLA-4 antibody: The anti-CTLA-4 antibody will be added concomitantly with INT230-6 as noted in cohort FEC.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
4
|
21
|
20
|
9
|
6
|
22
|
18
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
9
|
9
|
3
|
3
|
5
|
13
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
3
|
12
|
11
|
6
|
3
|
17
|
5
|
Reasons for withdrawal
| Measure |
Monotherapy: Cohort A1
A1:INT230-6 injections every 28 days for 5 sessions into only superficial tumors, low starting dose, low concentration per tumor.
|
Monotherapy: Cohort B1
B1:INT230-6 injections every 28 days for 5 sessions into deep tumors, low starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EA
EA:INT230-6 injections every 2 weeks for 5 sessions into superficial tumors, medium starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EC
EC:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, moderately high starting dose, high drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EC-2
EC2:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, high starting dose, moderate drug concentration per tumor, higher number of tumors to be treated per session than EC.
|
Monotherapy: Cohort EC3
EC3:INT230-6 injections every 2 weeks for 5 sessions at fixed maximal dose into superficial or deep tumors, unlimited number of tumors to be treated per session with retreatment once every 9 weeks for two years. Completed Cohort "
|
INT 230-6 Combined With Pembrolizumab (Cohort DEC)
DEC: INT230-6 injections every 2 weeks for 5 sessions with the possibility for INT230-6 retreatment into superficial tumors, with addition of anti-PD-1 antibody Keytruda (pembrolizumab) dosed concurrently starting at Day 1 every 3 weeks for two years for selected cancer types.
|
INT 230-6 Combined With Pembrolizumab (Cohort DEC2)
DEC2:INT230-6 per the dosing of cohort EC3 combined with Keytruda (pembrolizumab) dosed per DEC concurrently starting at Day 1 for selected cancers.
|
INT 230-6 Combined With Ipilimumab (Cohort FEC)
FEC: INT230-6 per the EC3 regimen combined with Yervoy (ipilimumab) dosed concurrently starting at Day 1 every 3 weeks for four treatments for selected cancer types.
Completed Cohort
anti-CTLA-4 antibody: The anti-CTLA-4 antibody will be added concomitantly with INT230-6 as noted in cohort FEC.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Radiographic Deterioration
|
0
|
3
|
1
|
2
|
6
|
3
|
0
|
4
|
2
|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
3
|
1
|
0
|
1
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
0
|
2
|
0
|
4
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
2
|
1
|
0
|
2
|
3
|
0
|
|
Overall Study
Clinical Deterioration
|
2
|
0
|
0
|
2
|
1
|
1
|
0
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Refused Further Treatment
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Rapid Progression of Disease
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6
Baseline characteristics by cohort
| Measure |
Monotherapy: (Cohort A1)
n=6 Participants
A1:INT230-6 injections every 28 days for 5 sessions into only superficial tumors, low starting dose, low concentration per tumor.
|
Monotherapy: (Cohort B1)
n=4 Participants
B1:INT230-6 injections every 28 days for 5 sessions into deep tumors, low starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: (Cohort E-A)
n=4 Participants
EA:INT230-6 injections every 2 weeks for 5 sessions into superficial tumors, medium starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: (Cohort E-C)
n=21 Participants
EC:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, moderately high starting dose, high drug concentration per tumor Completed Cohort
|
Monotherapy: (Cohort EC-2)
n=20 Participants
EC2:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, high starting dose, moderate drug concentration per tumor, higher number of tumors to be treated per session than EC.
|
Monotherapy: (Cohort EC3)
n=9 Participants
EC3:INT230-6 injections every 2 weeks for 5 sessions at fixed maximal dose into superficial or deep tumors, unlimited number of tumors to be treated per session with retreatment once every 9 weeks for two years. Completed Cohort
|
INT 230-6 Combined With Pembrolizumab (Cohort DEC)
n=6 Participants
DEC: INT230-6 injections every 2 weeks for 5 sessions with the possibility for INT230-6 retreatment into superficial tumors, with addition of anti-PD-1 antibody Keytruda (pembrolizumab) dosed concurrently starting at Day 1 every 3 weeks for two years for selected cancer types.
|
INT 230-6 Combined With Pembrolizumab (Cohort DEC2)
n=22 Participants
DEC2:INT230-6 per the dosing of cohort EC3 combined with Keytruda (pembrolizumab) dosed per DEC concurrently starting at Day 1 for selected cancers.
|
INT 230-6 Combined With Ipilimumab (Cohort FEC)
n=18 Participants
FEC: INT230-6 per the EC3 regimen combined with Yervoy (ipilimumab) dosed concurrently starting at Day 1 every 3 weeks for four treatments for selected cancer types.
Completed Cohort anti-CTLA-4 antibody: The anti-CTLA-4 antibody will be added concomitantly with INT230-6 as noted in cohort FEC.
|
Total
n=110 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
63 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
47 Participants
n=42 Participants
|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
64.6 years
STANDARD_DEVIATION 9.4 • n=21 Participants
|
61.5 years
STANDARD_DEVIATION 11.3 • n=8 Participants
|
64.2 years
STANDARD_DEVIATION 16 • n=8 Participants
|
68.4 years
STANDARD_DEVIATION 7.3 • n=24 Participants
|
64.2 years
STANDARD_DEVIATION 11.1 • n=42 Participants
|
62.9 years
STANDARD_DEVIATION 9.8 • n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
54 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
56 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
97 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
82 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
4 participants
n=8 Participants
|
1 participants
n=24 Participants
|
1 participants
n=42 Participants
|
11 participants
n=42 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
20 participants
n=4 Participants
|
19 participants
n=21 Participants
|
9 participants
n=8 Participants
|
2 participants
n=8 Participants
|
21 participants
n=24 Participants
|
17 participants
n=42 Participants
|
99 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsThe primary objective is to assess the safety and tolerability of single and multiple intratumoral doses of INT230-6 in subjects with advanced or recurrent malignancies. This will be assessed by the rate of ≥ grade 3 AE's attributed to INT230-6 and not the underlying disease. NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 (least severe) to 5 (most severe)) All recorded adverse events will be listed and tabulated by system organ class, preferred term, and dose and coded according to the most current version of MedDRA. The incidence of adverse events will be tabulated and reviewed for potential significance and clinical importance. Adverse Events will be summarized for all reported data and by study period: a) up to and including 28 days post last dose of initial treatment, and b) from first dose of re-initiation of treatment, for subjects who re-initiate study therapy while in follow-up, up to 28 days post-dose of the last re-treatment dose.
Outcome measures
| Measure |
Monotherapy: Cohort A1
n=6 Participants
A1:INT230-6 injections every 28 days for 5 sessions into only superficial tumors, low starting dose, low concentration per tumor.
|
Monotherapy: Cohort B1
n=4 Participants
B1:INT230-6 injections every 28 days for 5 sessions into deep tumors, low starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EA
n=4 Participants
EA:INT230-6 injections every 2 weeks for 5 sessions into superficial tumors, medium starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EC
n=21 Participants
EC:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, moderately high starting dose, high drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EC-2
n=20 Participants
EC2:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, high starting dose, moderate drug concentration per tumor, higher number of tumors to be treated per session than EC.
|
Monotherapy: Cohort EC3
n=9 Participants
EC3:INT230-6 injections every 2 weeks for 5 sessions at fixed maximal dose into superficial or deep tumors, unlimited number of tumors to be treated per session with retreatment once every 9 weeks for two years. Completed Cohort "
|
INT 230-6 Combined With Pembrolizumab (Cohort DEC)
n=6 Participants
DEC: INT230-6 injections every 2 weeks for 5 sessions with the possibility for INT230-6 retreatment into superficial tumors, with addition of anti-PD-1 antibody Keytruda (pembrolizumab) dosed concurrently starting at Day 1 every 3 weeks for two years for selected cancer types.
|
INT 230-6 Combined With Pembrolizumab (Cohort DEC2)
n=22 Participants
DEC2:INT230-6 per the dosing of cohort EC3 combined with Keytruda (pembrolizumab) dosed per DEC concurrently starting at Day 1 for selected cancers.
|
INT 230-6 Combined With Ipilimumab (Cohort FEC)
n=18 Participants
FEC: INT230-6 per the EC3 regimen combined with Yervoy (ipilimumab) dosed concurrently starting at Day 1 every 3 weeks for four treatments for selected cancer types.
Completed Cohort
anti-CTLA-4 antibody: The anti-CTLA-4 antibody will be added concomitantly with INT230-6 as noted in cohort FEC.
|
|---|---|---|---|---|---|---|---|---|---|
|
Rate and Severity of Treatment-emergent Adverse Events ≥ Grade 3 Attributed to Study Drug Using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 to 5)
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: The cohorts A1/B1/EA/EC/EC2/EC3 were all "INT230-6 Monotherapy Treatment" and used to evaluate safety. DEC/DEC2 were "INT230-6+Pembrolizumab " were also used to evaluate safety. Per the Statistical Analysis Plan (SAP) the monotherapy cohorts were combined to evaluate efficacy in relation to total tumor burden (TTB) at doses of \<40%TTB or ≥40%TTB for DCR. Per the SAP the pembrolizumab cohorts were combined to evaluate DCR.
Assess the preliminary efficacy of INT230-6 by measuring the disease control rate (CR+PR+SD) as assessed by iRECIST. Complete response (CR) and partial response (PR) will be defined for injected tumors followed per RECIST 1.1 utilizing target lesions. Progressive disease will be determined by clinical or radiological deterioration leading to the subject being taken off-treatment at the discretion of the investigator. Stable disease (SD) is defined as any adequate assessment not considered CR, PR, or progression.
Outcome measures
| Measure |
Monotherapy: Cohort A1
n=48 Participants
A1:INT230-6 injections every 28 days for 5 sessions into only superficial tumors, low starting dose, low concentration per tumor.
|
Monotherapy: Cohort B1
n=16 Participants
B1:INT230-6 injections every 28 days for 5 sessions into deep tumors, low starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EA
n=28 Participants
EA:INT230-6 injections every 2 weeks for 5 sessions into superficial tumors, medium starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EC
n=18 Participants
EC:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, moderately high starting dose, high drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EC-2
EC2:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, high starting dose, moderate drug concentration per tumor, higher number of tumors to be treated per session than EC.
|
Monotherapy: Cohort EC3
EC3:INT230-6 injections every 2 weeks for 5 sessions at fixed maximal dose into superficial or deep tumors, unlimited number of tumors to be treated per session with retreatment once every 9 weeks for two years. Completed Cohort "
|
INT 230-6 Combined With Pembrolizumab (Cohort DEC)
DEC: INT230-6 injections every 2 weeks for 5 sessions with the possibility for INT230-6 retreatment into superficial tumors, with addition of anti-PD-1 antibody Keytruda (pembrolizumab) dosed concurrently starting at Day 1 every 3 weeks for two years for selected cancer types.
|
INT 230-6 Combined With Pembrolizumab (Cohort DEC2)
DEC2:INT230-6 per the dosing of cohort EC3 combined with Keytruda (pembrolizumab) dosed per DEC concurrently starting at Day 1 for selected cancers.
|
INT 230-6 Combined With Ipilimumab (Cohort FEC)
FEC: INT230-6 per the EC3 regimen combined with Yervoy (ipilimumab) dosed concurrently starting at Day 1 every 3 weeks for four treatments for selected cancer types.
Completed Cohort
anti-CTLA-4 antibody: The anti-CTLA-4 antibody will be added concomitantly with INT230-6 as noted in cohort FEC.
|
|---|---|---|---|---|---|---|---|---|---|
|
Preliminary Efficacy: Assess the Preliminary Efficacy of INT230-6 by Measuring the Disease Control Rate (DCR) Based on the Response Evaluation Criteria in Solid Tumors (RECIST) and Immune RECIST (iRECIST) Criteria,
|
83.3 percentage (DCR)
|
50.0 percentage (DCR)
|
64.3 percentage (DCR)
|
83.3 percentage (DCR)
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: T = 1 hour after first dosePopulation: The pharmacokinetic (PK) analysis aggregated subjects into groups by the dose given per convention according to our SAP and PK plan. Characterization of Patients who received similar doses (2mL, 5mL, 10mL, 18 mL, 30 mL, 68 mL, 118 mL, etc.) from all the cohorts were aggregated per the plan. This methodology of grouping (as described in the PK report produces meaningful API and excipient blood concentration profiles and determines conventional PK parameters for those agents.
Characterize the peak plasma profile for the three INT230-6 components after single and then multiple IT tumor site injections for safety purposes. Timepoints for sample collection were T = 1 Hours after dosing. Mean dose volume categories that were used to summarize data were as follows: 2 mL (range 0 to 3.5 mL) 5 mL (range 3.6 to 6 mL) 10 mL (range \>6 to 12 mL) 17 mL (range \>12 to 24 mL) 30 mL (range \>24 mL to 44 mL) 68 mL (range \>44 to 98 mL) 118 mL (range \>98 to 175 mL)
Outcome measures
| Measure |
Monotherapy: Cohort A1
n=87 Participants
A1:INT230-6 injections every 28 days for 5 sessions into only superficial tumors, low starting dose, low concentration per tumor.
|
Monotherapy: Cohort B1
n=85 Participants
B1:INT230-6 injections every 28 days for 5 sessions into deep tumors, low starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EA
n=79 Participants
EA:INT230-6 injections every 2 weeks for 5 sessions into superficial tumors, medium starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EC
EC:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, moderately high starting dose, high drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EC-2
EC2:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, high starting dose, moderate drug concentration per tumor, higher number of tumors to be treated per session than EC.
|
Monotherapy: Cohort EC3
EC3:INT230-6 injections every 2 weeks for 5 sessions at fixed maximal dose into superficial or deep tumors, unlimited number of tumors to be treated per session with retreatment once every 9 weeks for two years. Completed Cohort "
|
INT 230-6 Combined With Pembrolizumab (Cohort DEC)
DEC: INT230-6 injections every 2 weeks for 5 sessions with the possibility for INT230-6 retreatment into superficial tumors, with addition of anti-PD-1 antibody Keytruda (pembrolizumab) dosed concurrently starting at Day 1 every 3 weeks for two years for selected cancer types.
|
INT 230-6 Combined With Pembrolizumab (Cohort DEC2)
DEC2:INT230-6 per the dosing of cohort EC3 combined with Keytruda (pembrolizumab) dosed per DEC concurrently starting at Day 1 for selected cancers.
|
INT 230-6 Combined With Ipilimumab (Cohort FEC)
FEC: INT230-6 per the EC3 regimen combined with Yervoy (ipilimumab) dosed concurrently starting at Day 1 every 3 weeks for four treatments for selected cancer types.
Completed Cohort
anti-CTLA-4 antibody: The anti-CTLA-4 antibody will be added concomitantly with INT230-6 as noted in cohort FEC.
|
|---|---|---|---|---|---|---|---|---|---|
|
Determine Pharmacokinetic Parameter Peak Plasma (Cmax in ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 5mL
|
77.81 ng/mL
Standard Deviation 38.16
|
113.7 ng/mL
Standard Deviation 83.2
|
.73 ng/mL
Standard Deviation .77
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Pharmacokinetic Parameter Peak Plasma (Cmax in ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 2mL
|
34.27 ng/mL
Standard Deviation 25.51
|
74.93 ng/mL
Standard Deviation 70.8
|
1.35 ng/mL
Standard Deviation 1.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Pharmacokinetic Parameter Peak Plasma (Cmax in ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 10mL
|
153.8 ng/mL
Standard Deviation 65.75
|
300.6 ng/mL
Standard Deviation 172.6
|
.75 ng/mL
Standard Deviation .33
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Pharmacokinetic Parameter Peak Plasma (Cmax in ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 17mL
|
245.8 ng/mL
Standard Deviation 119.3
|
426.8 ng/mL
Standard Deviation 306.6
|
1.24 ng/mL
Standard Deviation .67
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Pharmacokinetic Parameter Peak Plasma (Cmax in ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 30mL
|
456.5 ng/mL
Standard Deviation 195.0
|
911.6 ng/mL
Standard Deviation 790.1
|
3.16 ng/mL
Standard Deviation 1.99
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Pharmacokinetic Parameter Peak Plasma (Cmax in ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 68mL
|
952.2 ng/mL
Standard Deviation 503.8
|
1446 ng/mL
Standard Deviation 1245
|
5.63 ng/mL
Standard Deviation 2.33
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Pharmacokinetic Parameter Peak Plasma (Cmax in ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 118mL
|
1673 ng/mL
Standard Deviation 1276
|
2720 ng/mL
Standard Deviation 1848
|
9.52 ng/mL
Standard Deviation 4.52
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: T= 0, 1, 3, 6, 24 Hours after dosingPopulation: The pharmacokinetic (PK) analysis aggregated subjects into groups by the dose given per convention according to our SAP and PK plan. Characterization of Patients who received similar doses (2mL, 5mL, 10mL, 18 mL, 30 mL, 68 mL, 118 mL, etc.) from all the cohorts were aggregated per the plan. This methodology of grouping (as described in the PK report produces meaningful API and excipient blood concentration profiles and determines conventional PK parameters for those agents.
Characterize the pharmacokinetic AUC profile of each of the three INT230-6 components for AUC after single IT tumor site injection for safety purposes. Timepoints for sample collection were T = 0, 1, 3, 6, 24 Hours after dosing. Mean dose volume categories that were used to summarize data were as follows: 2 mL (range 0 to 3.5 mL) 5 mL (range 3.6 to 6 mL) 10 mL (range \>6 to 12 mL) 17 mL (range \>12 to 24 mL) 30 mL (range \>24 mL to 44 mL) 68 mL (range \>44 to 98 mL) 118 mL (range \>98 to 175 mL)
Outcome measures
| Measure |
Monotherapy: Cohort A1
n=87 Participants
A1:INT230-6 injections every 28 days for 5 sessions into only superficial tumors, low starting dose, low concentration per tumor.
|
Monotherapy: Cohort B1
n=85 Participants
B1:INT230-6 injections every 28 days for 5 sessions into deep tumors, low starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EA
n=79 Participants
EA:INT230-6 injections every 2 weeks for 5 sessions into superficial tumors, medium starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EC
EC:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, moderately high starting dose, high drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EC-2
EC2:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, high starting dose, moderate drug concentration per tumor, higher number of tumors to be treated per session than EC.
|
Monotherapy: Cohort EC3
EC3:INT230-6 injections every 2 weeks for 5 sessions at fixed maximal dose into superficial or deep tumors, unlimited number of tumors to be treated per session with retreatment once every 9 weeks for two years. Completed Cohort "
|
INT 230-6 Combined With Pembrolizumab (Cohort DEC)
DEC: INT230-6 injections every 2 weeks for 5 sessions with the possibility for INT230-6 retreatment into superficial tumors, with addition of anti-PD-1 antibody Keytruda (pembrolizumab) dosed concurrently starting at Day 1 every 3 weeks for two years for selected cancer types.
|
INT 230-6 Combined With Pembrolizumab (Cohort DEC2)
DEC2:INT230-6 per the dosing of cohort EC3 combined with Keytruda (pembrolizumab) dosed per DEC concurrently starting at Day 1 for selected cancers.
|
INT 230-6 Combined With Ipilimumab (Cohort FEC)
FEC: INT230-6 per the EC3 regimen combined with Yervoy (ipilimumab) dosed concurrently starting at Day 1 every 3 weeks for four treatments for selected cancer types.
Completed Cohort
anti-CTLA-4 antibody: The anti-CTLA-4 antibody will be added concomitantly with INT230-6 as noted in cohort FEC.
|
|---|---|---|---|---|---|---|---|---|---|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 5mL Timepoint: 0 Hours
|
1.56 ng/mL
Standard Deviation 4.67
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 5mL Timepoint: 1 Hour(s)
|
77.81 ng/mL
Standard Deviation 38.16
|
113.74 ng/mL
Standard Deviation 83.23
|
.65 ng/mL
Standard Deviation .76
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 5mL Timepoint: 3 Hours
|
58.50 ng/mL
Standard Deviation 30.57
|
11.43 ng/mL
Standard Deviation 15.52
|
.16 ng/mL
Standard Deviation .16
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 17mL Timepoint: 6 Hours
|
176.45 ng/mL
Standard Deviation 90.26
|
19.49 ng/mL
Standard Deviation 19.77
|
.51 ng/mL
Standard Deviation .29
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 68mL Timepoint: 24 Hours
|
610.08 ng/mL
Standard Deviation 264.39
|
2.71 ng/mL
Standard Deviation 6.44
|
.94 ng/mL
Standard Deviation .43
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 118mL Timepoint: 0 Hours
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
.08 ng/mL
Standard Deviation .17
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 118mL Timepoint: 6 Hours
|
779.67 ng/mL
Standard Deviation 360.88
|
183.43 ng/mL
Standard Deviation 99.64
|
3.08 ng/mL
Standard Deviation .85
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 2mL Timepoint: 6 Hours
|
25.35 ng/mL
Standard Deviation 20.35
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 2mL Timepoint: 24 Hours
|
20.74 ng/mL
Standard Deviation 17.22
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 2mL Time point: 0 Hours
|
6.38 ng/mL
Standard Deviation 20.18
|
0 ng/mL
Standard Deviation 0
|
.33 ng/mL
Standard Deviation 1.05
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 2mL Time point: 1 Hour(s)
|
33.78 ng/mL
Standard Deviation 24.92
|
59.94 ng/mL
Standard Deviation 69.95
|
.08 ng/mL
Standard Deviation .16
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 2mL Timepoint: 3 Hours
|
28.09 ng/mL
Standard Deviation 23.16
|
3.33 ng/mL
Standard Deviation 6.99
|
.04 ng/mL
Standard Deviation .12
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 5mL Timepoint: 6 Hours
|
59.04 ng/mL
Standard Deviation 32.03
|
2.18 ng/mL
Standard Deviation 6.15
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 5mL Timepoint: 24 Hours
|
53.87 ng/mL
Standard Deviation 29.07
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 10mL Timepoint: 0 Hours
|
4.95 ng/mL
Standard Deviation 13.09
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 10mL Timepoint: 1 Hour(s)
|
152.63 ng/mL
Standard Deviation 67.36
|
300.56 ng/mL
Standard Deviation 172.62
|
.74 ng/mL
Standard Deviation .35
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 10mL Timepoint: 3 Hours
|
114.7 ng/mL
Standard Deviation 53.38
|
36.68 ng/mL
Standard Deviation 51.13
|
.39 ng/mL
Standard Deviation .22
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 10mL Timepoint: 6 Hours
|
111.57 ng/mL
Standard Deviation 49.37
|
6.21 ng/mL
Standard Deviation 15.22
|
.34 ng/mL
Standard Deviation .1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 10mL Timepoint: 24 Hours
|
100.98 ng/mL
Standard Deviation 52.36
|
0 ng/mL
Standard Deviation 0
|
.05 ng/mL
Standard Deviation .12
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 17mL Timepoint: 0 Hours
|
4.99 ng/mL
Standard Deviation 19.50
|
0 ng/mL
Standard Deviation 0
|
.01 ng/mL
Standard Deviation .06
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 17mL Timepoint: 1 Hours
|
233.15 ng/mL
Standard Deviation 125.77
|
426.75 ng/mL
Standard Deviation 306.59
|
1.2 ng/mL
Standard Deviation .72
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 17mL Timepoint: 3 Hours
|
187.08 ng/mL
Standard Deviation 93.22
|
59.76 ng/mL
Standard Deviation 45.33
|
.66 ng/mL
Standard Deviation .35
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 17mL Timepoint:24 Hours
|
163.87 ng/mL
Standard Deviation 90.19
|
.5 ng/mL
Standard Deviation 2.27
|
.17 ng/mL
Standard Deviation .24
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 30mL Timepoint: 0 Hours
|
7.15 ng/mL
Standard Deviation 19.24
|
0.0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 30mL Timepoint: 1 Hours
|
456.47 ng/mL
Standard Deviation 195.02
|
911.55 ng/mL
Standard Deviation 790.14
|
3.16 ng/mL
Standard Deviation 1.99
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 30mL Timepoint: 3 Hours
|
344.82 ng/mL
Standard Deviation 163.12
|
95.67 ng/mL
Standard Deviation 64.38
|
1.44 ng/mL
Standard Deviation .77
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 30mL Timepoint: 6 Hours
|
325.73 ng/mL
Standard Deviation 152.91
|
26.95 ng/mL
Standard Deviation 20.34
|
1.06 ng/mL
Standard Deviation .58
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 30mL Timepoint: 24 Hours
|
295.42 ng/mL
Standard Deviation 137.46
|
.78 ng/mL
Standard Deviation 3.20
|
.47 ng/mL
Standard Deviation .38
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 68mL Timepoint: 0 Hours
|
62.93 ng/mL
Standard Deviation 222.70
|
289.23 ng/mL
Standard Deviation 1042.84
|
.44 ng/mL
Standard Deviation 1.58
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 68mL Timepoint: 1 Hours
|
832.92 ng/mL
Standard Deviation 192.93
|
1286.00 ng/mL
Standard Deviation 1039.43
|
5.53 ng/mL
Standard Deviation 2.35
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 68mL Timepoint: 3 Hours
|
741.92 ng/mL
Standard Deviation 343.37
|
240.82 ng/mL
Standard Deviation 276.13
|
2.73 ng/mL
Standard Deviation .72
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 68mL Timepoint: 6 Hours
|
775.00 ng/mL
Standard Deviation 581.44
|
96.54 ng/mL
Standard Deviation 146.88
|
1.94 ng/mL
Standard Deviation .55
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 118mL Timepoint: 1 Hours
|
1664 ng/mL
Standard Deviation 1287.53
|
2719.75 ng/mL
Standard Deviation 1848.17
|
9.52 ng/mL
Standard Deviation 4.52
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 118mL Timepoint: 3 Hours
|
875 ng/mL
Standard Deviation 433.39
|
459.67 ng/mL
Standard Deviation 289.46
|
4.33 ng/mL
Standard Deviation 1.46
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determine Key Pharmacokinetic Parameter, Area Under the Curve (AUC) (ng/mL) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 118mL Timepoint: 24 Hours
|
945.33 ng/mL
Standard Deviation 544.78
|
21.93 ng/mL
Standard Deviation 24.84
|
1.24 ng/mL
Standard Deviation 1.19
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: T= 0, 1, 3, 6, 24 hoursPopulation: The pharmacokinetic (PK) analysis aggregated subjects into groups by the dose given per convention according to our SAP and PK plan. Characterization of Patients who received similar doses (2mL, 5mL, 10mL, 18 mL, 30 mL, 68 mL, 118 mL, etc.) from all the cohorts were aggregated per the plan. This methodology of grouping (as described in the PK report produces meaningful API and excipient blood concentration profiles and determines conventional PK parameters for those agents.
Characterize the half life of each of the three INT230-6 components after single and multiple IT tumor site injections for safety purposes. Timepoints for sample collection were T = 0, 1, 3, 6, 24 Hours after dosing. Mean dose volume categories that were used to summarize data were as follows: 2 mL (range 0 to 3.5 mL) 5 mL (range 3.6 to 6 mL) 10 mL (range \>6 to 12 mL) 17 mL (range \>12 to 24 mL) 30 mL (range \>24 mL to 44 mL) 68 mL (range \>44 to 98 mL) 118 mL (range \>98 to 175 mL)
Outcome measures
| Measure |
Monotherapy: Cohort A1
n=26 Participants
A1:INT230-6 injections every 28 days for 5 sessions into only superficial tumors, low starting dose, low concentration per tumor.
|
Monotherapy: Cohort B1
n=6 Participants
B1:INT230-6 injections every 28 days for 5 sessions into deep tumors, low starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EA
n=28 Participants
EA:INT230-6 injections every 2 weeks for 5 sessions into superficial tumors, medium starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EC
EC:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, moderately high starting dose, high drug concentration per tumor Completed Cohort
|
Monotherapy: Cohort EC-2
EC2:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, high starting dose, moderate drug concentration per tumor, higher number of tumors to be treated per session than EC.
|
Monotherapy: Cohort EC3
EC3:INT230-6 injections every 2 weeks for 5 sessions at fixed maximal dose into superficial or deep tumors, unlimited number of tumors to be treated per session with retreatment once every 9 weeks for two years. Completed Cohort "
|
INT 230-6 Combined With Pembrolizumab (Cohort DEC)
DEC: INT230-6 injections every 2 weeks for 5 sessions with the possibility for INT230-6 retreatment into superficial tumors, with addition of anti-PD-1 antibody Keytruda (pembrolizumab) dosed concurrently starting at Day 1 every 3 weeks for two years for selected cancer types.
|
INT 230-6 Combined With Pembrolizumab (Cohort DEC2)
DEC2:INT230-6 per the dosing of cohort EC3 combined with Keytruda (pembrolizumab) dosed per DEC concurrently starting at Day 1 for selected cancers.
|
INT 230-6 Combined With Ipilimumab (Cohort FEC)
FEC: INT230-6 per the EC3 regimen combined with Yervoy (ipilimumab) dosed concurrently starting at Day 1 every 3 weeks for four treatments for selected cancer types.
Completed Cohort
anti-CTLA-4 antibody: The anti-CTLA-4 antibody will be added concomitantly with INT230-6 as noted in cohort FEC.
|
|---|---|---|---|---|---|---|---|---|---|
|
Key Pharmacokinetic Parameters, Half Live (Hours) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 2mL
|
77.98 Hours
Standard Deviation 34.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Key Pharmacokinetic Parameters, Half Live (Hours) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 5mL
|
130.4 Hours
Standard Deviation 129.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Key Pharmacokinetic Parameters, Half Live (Hours) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 10mL
|
106.3 Hours
Standard Deviation 53.58
|
—
|
18.82 Hours
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Key Pharmacokinetic Parameters, Half Live (Hours) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 17mL
|
78.73 Hours
Standard Deviation 66.36
|
7.33 Hours
|
20.11 Hours
Standard Deviation 7.45
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Key Pharmacokinetic Parameters, Half Live (Hours) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 30mL
|
64.77 Hours
Standard Deviation 15.18
|
7.48 Hours
|
15.35 Hours
Standard Deviation 4.38
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Key Pharmacokinetic Parameters, Half Live (Hours) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 68mL
|
129.4 Hours
Standard Deviation 125.5
|
3.91 Hours
Standard Deviation 2.6
|
14.06 Hours
Standard Deviation 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Key Pharmacokinetic Parameters, Half Live (Hours) of Each of the 3 Main Components of INT230-6.
Mean INT230-6 Dose Category: 118mL
|
—
|
6.18 Hours
|
24.48 Hours
Standard Deviation 4.76
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 monthsCharacterize response in non-injected lesions (up to 5) using length (cm) as the key parameter for measurement.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 monthsEvaluate various tumor and anti-tumor immune response biomarkers from blood, tumor tissue that may correlate with tumor response. Flow and tissue panels may include Live-Dead, CD3, CD4, CD8, FoxP3, Ki-67, ICOS, DAPI, PD-1, LAG-3, TIM-3, CTLA-4 and analysis of blood serum cytokine such as Th1/Th2, IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 p70, IL-13, and TNF-α.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsEvaluate overall response by iRECIST including survival
Outcome measures
Outcome data not reported
Adverse Events
Monotherapy: (Cohort A1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Monotherapy: (Cohort B1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Monotherapy: (Cohort E-A)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Monotherapy: (Cohort E-C)
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Monotherapy: (Cohort EC-2)
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Monotherapy: (Cohort EC3)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
INT230-6 Combined With Pembrolizumab (Cohorts DEC)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
INT230-6 Combined With Pembrolizumab (Cohorts DEC2)
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
INT 230-6 Combined With Ipilimumab (Cohort FEC)
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Monotherapy: (Cohort A1)
n=6 participants at risk
A1:INT230-6 injections every 28 days for 5 sessions into only superficial tumors, low starting dose, low concentration per tumor.
Completed Cohort
|
Monotherapy: (Cohort B1)
n=4 participants at risk
B1:INT230-6 injections every 28 days for 5 sessions into deep tumors, low starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: (Cohort E-A)
n=4 participants at risk
EA:INT230-6 injections every 2 weeks for 5 sessions into superficial tumors, medium starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: (Cohort E-C)
n=21 participants at risk
EC:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, moderately high starting dose, high drug concentration per tumor Completed Cohort
|
Monotherapy: (Cohort EC-2)
n=20 participants at risk
EC2:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, high starting dose, moderate drug concentration per tumor, higher number of tumors to be treated per session than EC.
Completed Cohort
|
Monotherapy: (Cohort EC3)
n=9 participants at risk
EC3:INT230-6 injections every 2 weeks for 5 sessions at fixed maximal dose into superficial or deep tumors, unlimited number of tumors to be treated per session with retreatment once every 9 weeks for two years. Completed Cohort
|
INT230-6 Combined With Pembrolizumab (Cohorts DEC)
n=8 participants at risk
DEC: INT230-6 injections every 2 weeks for 5 sessions with the possibility for INT230-6 retreatment into superficial tumors, with addition of anti-PD-1 antibody KEYTRUDA® (pembrolizumab) dosed concurrently starting at Day 1 every 3 weeks for two years for selected cancer types.
Completed Cohort
|
INT230-6 Combined With Pembrolizumab (Cohorts DEC2)
n=22 participants at risk
DEC2:INT230-6 per the dosing of cohort EC3 combined with KEYTRUDA® (pembrolizumab) dosed per DEC concurrently starting at Day 1 for selected cancers.
|
INT 230-6 Combined With Ipilimumab (Cohort FEC)
n=18 participants at risk
FEC: INT230-6 per the EC3 regimen combined with Yervoy (ipilimumab) dosed concurrently starting at Day 1 every 3 weeks for four treatments for selected cancer types.
Completed Cohort anti-CTLA-4 antibody: The anti-CTLA-4 antibody will be added concomitantly with INT230-6 as noted in cohort FEC.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
12.5%
1/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.5%
1/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
12.5%
1/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.5%
1/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
General disorders
Localized Tumor Related Pain
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
11.1%
1/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
Other adverse events
| Measure |
Monotherapy: (Cohort A1)
n=6 participants at risk
A1:INT230-6 injections every 28 days for 5 sessions into only superficial tumors, low starting dose, low concentration per tumor.
Completed Cohort
|
Monotherapy: (Cohort B1)
n=4 participants at risk
B1:INT230-6 injections every 28 days for 5 sessions into deep tumors, low starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: (Cohort E-A)
n=4 participants at risk
EA:INT230-6 injections every 2 weeks for 5 sessions into superficial tumors, medium starting dose, low drug concentration per tumor Completed Cohort
|
Monotherapy: (Cohort E-C)
n=21 participants at risk
EC:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, moderately high starting dose, high drug concentration per tumor Completed Cohort
|
Monotherapy: (Cohort EC-2)
n=20 participants at risk
EC2:INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, high starting dose, moderate drug concentration per tumor, higher number of tumors to be treated per session than EC.
Completed Cohort
|
Monotherapy: (Cohort EC3)
n=9 participants at risk
EC3:INT230-6 injections every 2 weeks for 5 sessions at fixed maximal dose into superficial or deep tumors, unlimited number of tumors to be treated per session with retreatment once every 9 weeks for two years. Completed Cohort
|
INT230-6 Combined With Pembrolizumab (Cohorts DEC)
n=8 participants at risk
DEC: INT230-6 injections every 2 weeks for 5 sessions with the possibility for INT230-6 retreatment into superficial tumors, with addition of anti-PD-1 antibody KEYTRUDA® (pembrolizumab) dosed concurrently starting at Day 1 every 3 weeks for two years for selected cancer types.
Completed Cohort
|
INT230-6 Combined With Pembrolizumab (Cohorts DEC2)
n=22 participants at risk
DEC2:INT230-6 per the dosing of cohort EC3 combined with KEYTRUDA® (pembrolizumab) dosed per DEC concurrently starting at Day 1 for selected cancers.
|
INT 230-6 Combined With Ipilimumab (Cohort FEC)
n=18 participants at risk
FEC: INT230-6 per the EC3 regimen combined with Yervoy (ipilimumab) dosed concurrently starting at Day 1 every 3 weeks for four treatments for selected cancer types.
Completed Cohort anti-CTLA-4 antibody: The anti-CTLA-4 antibody will be added concomitantly with INT230-6 as noted in cohort FEC.
|
|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
11.1%
1/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
General disorders
Chills
|
16.7%
1/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
11.1%
2/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
25.0%
1/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
11.1%
1/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
11.1%
2/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
General disorders
Injection Site Induration
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
General disorders
Injection Site Odema
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Gastrointestinal disorders
Abdominal Distention
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Infections and infestations
Wound Infection
|
16.7%
1/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Blister
|
16.7%
1/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
General disorders
Localized Tumor-Related Pain
|
33.3%
2/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
50.0%
2/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
75.0%
3/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
61.9%
13/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
70.0%
14/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
66.7%
6/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
62.5%
5/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
45.5%
10/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
50.0%
9/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
52.4%
11/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
50.0%
10/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
55.6%
5/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
25.0%
2/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
9.1%
2/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
22.2%
4/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
52.4%
11/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
40.0%
8/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
27.3%
6/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
33.3%
6/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
General disorders
Malaise
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
33.3%
7/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
35.0%
7/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
11.1%
1/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
12.5%
1/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
13.6%
3/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
11.1%
2/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
14.3%
3/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
11.1%
1/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
12.5%
1/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
11.1%
2/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
47.6%
10/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
30.0%
6/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
11.1%
1/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
37.5%
3/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
13.6%
3/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
16.7%
3/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
16.7%
1/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
General disorders
Injection Site Erythema
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
25.0%
1/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
10.0%
2/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
9.5%
2/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
30.0%
6/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
9.1%
2/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
11.1%
2/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
19.0%
4/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
10.0%
2/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
General disorders
Injection Site Reaction
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
10.0%
2/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
11.1%
1/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
9.1%
2/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
22.2%
2/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
14.3%
3/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
11.1%
1/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
18.2%
4/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
11.1%
1/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
12.5%
1/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.5%
1/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
16.7%
3/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
9.5%
2/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
9.1%
2/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
16.7%
3/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
25.0%
1/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
12.5%
1/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
11.1%
2/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
9.5%
2/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Nervous system disorders
Parathesia
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperglcaemia
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
12.5%
1/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
9.1%
2/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
12.5%
1/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
13.6%
3/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Necrosis
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Reproductive system and breast disorders
Pruritus Genital
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.6%
1/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
9.1%
2/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
9.1%
2/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
9.1%
2/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Investigations
Gamma-Glutamyl Transferase Increased
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
9.1%
2/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
9.5%
2/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
9.5%
2/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
25.0%
1/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
General disorders
Axillary Pain
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
12.5%
1/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
General disorders
Injection Site Bruising
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
12.5%
1/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
12.5%
1/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
12.5%
1/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
10.0%
2/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Gastrointestinal disorders
Abdominal Upper Pain
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Palmer Plantar Erythrodysaesthesia
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
11.1%
1/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
5.0%
1/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
General disorders
Face Oedema
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
25.0%
1/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
General disorders
Injection Site Haemorrhage
|
16.7%
1/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
General disorders
Mucosal Inflammation
|
16.7%
1/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
General disorders
Swelling
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
25.0%
1/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
General disorders
Swelling Face
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
25.0%
1/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Gastrointestinal disorders
Swollen Tongue
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
25.0%
1/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/4 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
4.8%
1/21 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/20 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/9 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
12.5%
1/8 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/22 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
0.00%
0/18 • Each patient would have their Adverse Events recorded starting at the first dose until 28 days after the last dose. up to 5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60