Trial Outcomes & Findings for APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma (NCT NCT02706353)
NCT ID: NCT02706353
Last Updated: 2025-11-21
Results Overview
To assess safety and tolerability of intratumoral APX005M given with systemic pembrolizumab and identify of the maximum tolerated dose/recommended phase 2 dose (MTD/PR2D) of the combination therapy in patients with metastatic melanoma.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Baseline to 2 years
Results posted on
2025-11-21
Participant Flow
Dose Escalation and Cohort Expansion of Safety and Tolerability of Intratumoral CD40 Agonistic Monoclonal Antibody APX005M in Combination with Systemic Pembrolizumab.
40 subjects consented; 6 pts not eligible; 32 subjects treated \& 2 subjects in the Expansion Phase withdrew consent prior to screening assessments
Participant milestones
| Measure |
Phase 1: Dose Escalation (0.5 mg)
IT APX005M DL 1-DL 5 0.5 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (1 mg)
IT APX005M DL 1-DL 5 1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (3 mg)
IT APX005M DL 1-DL 5 3 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (10 mg)
IT APX005M DL 1-DL 5 10 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 2: Dose Expansion
IT APX005M 10 mg q3 wks \& Pembrolizumab IV 200 mg (flat dose) q3 wks
|
Phase 1: Dose Escalation (0.1 mg)
IT APX005M DL 1-DL 5 0.1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
|---|---|---|---|---|---|---|
|
Dose Level 2
STARTED
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level 1
STARTED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Dose Level 1
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Dose Level 2
COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level 3
STARTED
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Dose Level 3
COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Dose Level 3
NOT COMPLETED
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Dose Level 4
STARTED
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Dose Level 4
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level 4
NOT COMPLETED
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Dose Level 5
STARTED
|
0
|
0
|
0
|
6
|
20
|
0
|
|
Dose Level 5
COMPLETED
|
0
|
0
|
0
|
1
|
10
|
0
|
|
Dose Level 5
NOT COMPLETED
|
0
|
0
|
0
|
5
|
10
|
0
|
Reasons for withdrawal
| Measure |
Phase 1: Dose Escalation (0.5 mg)
IT APX005M DL 1-DL 5 0.5 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (1 mg)
IT APX005M DL 1-DL 5 1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (3 mg)
IT APX005M DL 1-DL 5 3 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (10 mg)
IT APX005M DL 1-DL 5 10 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 2: Dose Expansion
IT APX005M 10 mg q3 wks \& Pembrolizumab IV 200 mg (flat dose) q3 wks
|
Phase 1: Dose Escalation (0.1 mg)
IT APX005M DL 1-DL 5 0.1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
|---|---|---|---|---|---|---|
|
Dose Level 1
Disease Progression
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Dose Level 3
Disease Progression
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Dose Level 4
Disease Progression
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Dose Level 4
Toxicity
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Dose Level 4
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Dose Level 5
Toxicity
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Dose Level 5
Disease Progression
|
0
|
0
|
0
|
3
|
2
|
0
|
|
Dose Level 5
Death
|
0
|
0
|
0
|
1
|
6
|
0
|
|
Dose Level 5
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Phase 1: Dose Escalation
n=1 Participants
IT APX005M DL 1-DL 5 0.1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (0.5 mg)
n=1 Participants
IT APX005M DL 1-DL 5 0.5 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (1 mg)
n=3 Participants
IT APX005M DL 1-DL 5 1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (3 mg)
n=3 Participants
IT APX005M DL 1-DL 5 3 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (10 mg)
n=6 Participants
IT APX005M DL 1-DL 5 10 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 2: Dose Expansion
n=20 Participants
IT APX005M 10 mg q3 wks \& Pembrolizumab IV 200 mg (flat dose) q3 wks
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
2 Participants
n=60 Participants
|
2 Participants
n=185 Participants
|
4 Participants
n=740 Participants
|
7 Participants
n=3 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=185 Participants
|
2 Participants
n=740 Participants
|
13 Participants
n=3 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
2 Participants
n=740 Participants
|
4 Participants
n=3 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
2 Participants
n=60 Participants
|
3 Participants
n=185 Participants
|
4 Participants
n=740 Participants
|
16 Participants
n=3 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
3 Participants
n=60 Participants
|
2 Participants
n=185 Participants
|
6 Participants
n=740 Participants
|
18 Participants
n=3 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
3 Participants
n=60 Participants
|
3 Participants
n=185 Participants
|
5 Participants
n=740 Participants
|
19 Participants
n=3 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
1 Participants
n=740 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=39 Participants
|
1 participants
n=29 Participants
|
3 participants
n=60 Participants
|
3 participants
n=185 Participants
|
6 participants
n=740 Participants
|
18 participants
n=3 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2 yearsTo assess safety and tolerability of intratumoral APX005M given with systemic pembrolizumab and identify of the maximum tolerated dose/recommended phase 2 dose (MTD/PR2D) of the combination therapy in patients with metastatic melanoma.
Outcome measures
| Measure |
Phase 1: Dose Escalation
n=14 Participants
IT APX005M DL 1-DL 5 0.1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 2: Dose Expansion
n=18 Participants
IT APX005M 10 mg q3 wks \& Pembrolizumab IV 200 mg (flat dose) q3 wks
|
Phase 1: Dose Escalation (1 mg)
IT APX005M DL 1-DL 5 1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (3 mg)
IT APX005M DL 1-DL 5 3 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (10 mg)
IT APX005M DL 1-DL 5 10 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 2: Dose Expansion
IT APX005M 10 mg q3 wks \& Pembrolizumab IV 200 mg (flat dose) q3 wks
|
|---|---|---|---|---|---|---|
|
Safety and Tolerability
|
10 mg
|
10 mg
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to 2 yearsTo assess best overall response after ibtratumoral injection of APX005M in combination with systemic pembrolizumab
Outcome measures
| Measure |
Phase 1: Dose Escalation
n=1 Participants
IT APX005M DL 1-DL 5 0.1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 2: Dose Expansion
n=1 Participants
IT APX005M 10 mg q3 wks \& Pembrolizumab IV 200 mg (flat dose) q3 wks
|
Phase 1: Dose Escalation (1 mg)
n=3 Participants
IT APX005M DL 1-DL 5 1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (3 mg)
n=3 Participants
IT APX005M DL 1-DL 5 3 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (10 mg)
n=6 Participants
IT APX005M DL 1-DL 5 10 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 2: Dose Expansion
n=18 Participants
IT APX005M 10 mg q3 wks \& Pembrolizumab IV 200 mg (flat dose) q3 wks
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
66.7 percentage of participants
|
50 percentage of participants
|
50 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to week 6Population: Although 32 patients were enrolled in the study, only 26 were included in the biomarker analyses. The remaining 6 were excluded due to issues such as insufficient or poor-quality tumor tissue and/or the absence of paired tumor samples necessary for direct comparisons.
To comprehensively assess CD8⁺ T cell responses in injected tumors, we employed multiplex immunofluorescence (mIF).
Outcome measures
| Measure |
Phase 1: Dose Escalation
n=1 Participants
IT APX005M DL 1-DL 5 0.1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 2: Dose Expansion
n=1 Participants
IT APX005M 10 mg q3 wks \& Pembrolizumab IV 200 mg (flat dose) q3 wks
|
Phase 1: Dose Escalation (1 mg)
n=2 Participants
IT APX005M DL 1-DL 5 1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (3 mg)
n=3 Participants
IT APX005M DL 1-DL 5 3 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (10 mg)
n=6 Participants
IT APX005M DL 1-DL 5 10 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 2: Dose Expansion
n=13 Participants
IT APX005M 10 mg q3 wks \& Pembrolizumab IV 200 mg (flat dose) q3 wks
|
|---|---|---|---|---|---|---|
|
Evaluation of Intratumoral CD8⁺ T Cells
|
12.04 density cells/mm^2
|
1409.18 density cells/mm^2
|
-24.62 density cells/mm^2
Standard Deviation 42.21
|
17.60 density cells/mm^2
Standard Deviation 68.98
|
415.92 density cells/mm^2
Standard Deviation 695.56
|
388.1 density cells/mm^2
Standard Deviation 435.1
|
SECONDARY outcome
Timeframe: Baseline to 2 yearsTo assess the overall safety and tolerability of IT APX005M given with systemic pembrolizumab in patients with metastatic melanoma.
Outcome measures
| Measure |
Phase 1: Dose Escalation
n=1 Participants
IT APX005M DL 1-DL 5 0.1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 2: Dose Expansion
n=1 Participants
IT APX005M 10 mg q3 wks \& Pembrolizumab IV 200 mg (flat dose) q3 wks
|
Phase 1: Dose Escalation (1 mg)
n=3 Participants
IT APX005M DL 1-DL 5 1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (3 mg)
n=3 Participants
IT APX005M DL 1-DL 5 3 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (10 mg)
n=6 Participants
IT APX005M DL 1-DL 5 10 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 2: Dose Expansion
n=18 Participants
IT APX005M 10 mg q3 wks \& Pembrolizumab IV 200 mg (flat dose) q3 wks
|
|---|---|---|---|---|---|---|
|
Overall Safety and Tolerability
|
0 grade 3/grade 4 events
|
1 grade 3/grade 4 events
|
1 grade 3/grade 4 events
|
12 grade 3/grade 4 events
|
5 grade 3/grade 4 events
|
28 grade 3/grade 4 events
|
SECONDARY outcome
Timeframe: Baseline to 2 yearsTo evaluate anti-tumor immune responses and clinical efficacy of intratumoral injection of IT APX005M with systemic Pembrolizumab
Outcome measures
| Measure |
Phase 1: Dose Escalation
n=1 Participants
IT APX005M DL 1-DL 5 0.1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 2: Dose Expansion
n=1 Participants
IT APX005M 10 mg q3 wks \& Pembrolizumab IV 200 mg (flat dose) q3 wks
|
Phase 1: Dose Escalation (1 mg)
n=3 Participants
IT APX005M DL 1-DL 5 1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (3 mg)
n=3 Participants
IT APX005M DL 1-DL 5 3 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (10 mg)
n=6 Participants
IT APX005M DL 1-DL 5 10 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks
Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 2: Dose Expansion
n=18 Participants
IT APX005M 10 mg q3 wks \& Pembrolizumab IV 200 mg (flat dose) q3 wks
|
|---|---|---|---|---|---|---|
|
Anti-tumor Immune Responses and Clinical Efficacy
|
0.00 percentage of participants
Interval 0.0 to 98.8
|
0.00 percentage of participants
Interval 0.0 to 98.8
|
33.3 percentage of participants
Interval 0.4 to 93.4
|
66.70 percentage of participants
Interval 6.6 to 99.6
|
50.00 percentage of participants
Interval 9.2 to 90.8
|
50.00 percentage of participants
Interval 23.4 to 76.6
|
Adverse Events
Phase 1: Dose Escalation (0.1 mg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1: Dose Escalation (0.5 mg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1: Dose Escalation (1 mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1: Dose Escalation (3 mg)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1: Dose Escalation (10 mg)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 2: Dose Expansion
Serious events: 9 serious events
Other events: 18 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Phase 1: Dose Escalation (0.1 mg)
n=1 participants at risk
IT APX005M DL 1-DL 5 0.1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (0.5 mg)
n=1 participants at risk
IT APX005M DL 1-DL 5 0.5 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (1 mg)
n=3 participants at risk
IT APX005M DL 1-DL 5 1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (3 mg)
n=3 participants at risk
IT APX005M DL 1-DL 5 3 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (10 mg)
n=6 participants at risk
IT APX005M DL 1-DL 5 10 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 2: Dose Expansion
n=20 participants at risk
IT APX005M 10 mg q3 wks \& Pembrolizumab IV 200 mg (flat dose) q3 wks
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Intra-abdominal hemorrhage
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Gastrointestinal disorders
Abdominal hiatial hernia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Infections and infestations
Pneumonitis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Investigations
ALT increased
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Nervous system disorders
Acute Saddle PE
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Cardiac disorders
Myocardial Infaraction
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Vascular disorders
Thromeoemeolic Event
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
Other adverse events
| Measure |
Phase 1: Dose Escalation (0.1 mg)
n=1 participants at risk
IT APX005M DL 1-DL 5 0.1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (0.5 mg)
n=1 participants at risk
IT APX005M DL 1-DL 5 0.5 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (1 mg)
n=3 participants at risk
IT APX005M DL 1-DL 5 1 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (3 mg)
n=3 participants at risk
IT APX005M DL 1-DL 5 3 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 1: Dose Escalation (10 mg)
n=6 participants at risk
IT APX005M DL 1-DL 5 10 mg q3 wks \& Pembrolizumab 2 mg/kg (mas 200 mg) q3 wks Dose level 1 = 0.1 mg Dose level 2 = 0.5 mg Dose level 3 = 1 mg Dose level 4 = 3 mg Dose level 5 = 10 mg
|
Phase 2: Dose Expansion
n=20 participants at risk
IT APX005M 10 mg q3 wks \& Pembrolizumab IV 200 mg (flat dose) q3 wks
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
General disorders
Gait disturbance
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Gastrointestinal disorders
Sigmoid diverticulitis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
2/6 • Number of events 2 • Baseline to 2 years
|
25.0%
5/20 • Number of events 5 • Baseline to 2 years
|
|
Vascular disorders
Hematoma
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
33.3%
2/6 • Number of events 2 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
General disorders
Edema- injection site
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 3 • Baseline to 2 years
|
|
General disorders
Hip pain
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 4 • Baseline to 2 years
|
35.0%
7/20 • Number of events 15 • Baseline to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
1/1 • Number of events 3 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
66.7%
2/3 • Number of events 4 • Baseline to 2 years
|
100.0%
3/3 • Number of events 24 • Baseline to 2 years
|
83.3%
5/6 • Number of events 18 • Baseline to 2 years
|
70.0%
14/20 • Number of events 32 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
35.0%
7/20 • Number of events 7 • Baseline to 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
20.0%
4/20 • Number of events 5 • Baseline to 2 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
66.7%
2/3 • Number of events 5 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
50.0%
3/6 • Number of events 7 • Baseline to 2 years
|
35.0%
7/20 • Number of events 7 • Baseline to 2 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
15.0%
3/20 • Number of events 3 • Baseline to 2 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 3 • Baseline to 2 years
|
66.7%
2/3 • Number of events 2 • Baseline to 2 years
|
16.7%
1/6 • Number of events 2 • Baseline to 2 years
|
30.0%
6/20 • Number of events 16 • Baseline to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 3 • Baseline to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
66.7%
2/3 • Number of events 4 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
10.0%
2/20 • Number of events 3 • Baseline to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 2 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
10.0%
2/20 • Number of events 4 • Baseline to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
100.0%
3/3 • Number of events 12 • Baseline to 2 years
|
33.3%
2/6 • Number of events 3 • Baseline to 2 years
|
55.0%
11/20 • Number of events 15 • Baseline to 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 4 • Baseline to 2 years
|
16.7%
1/6 • Number of events 2 • Baseline to 2 years
|
40.0%
8/20 • Number of events 15 • Baseline to 2 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
66.7%
2/3 • Number of events 4 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
20.0%
4/20 • Number of events 4 • Baseline to 2 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 2 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Infections and infestations
Infection Cellulitis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 2 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Infections and infestations
Cellulitis prophylaxis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Infections and infestations
Infection Oral Thrush
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Infections and infestations
Injection site reaction
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
45.0%
9/20 • Number of events 33 • Baseline to 2 years
|
|
General disorders
Infusion related action
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 2 • Baseline to 2 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
10.0%
2/20 • Number of events 2 • Baseline to 2 years
|
|
Investigations
INR increased
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 3 • Baseline to 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 2 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
General disorders
Localized edema
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 4 • Baseline to 2 years
|
83.3%
5/6 • Number of events 15 • Baseline to 2 years
|
65.0%
13/20 • Number of events 40 • Baseline to 2 years
|
|
Vascular disorders
Lymphedema
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
General disorders
Malaise
|
100.0%
1/1 • Number of events 1 • Baseline to 2 years
|
100.0%
1/1 • Number of events 1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
20.0%
4/20 • Number of events 7 • Baseline to 2 years
|
|
Musculoskeletal and connective tissue disorders
Left knee swollen
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Musculoskeletal and connective tissue disorders
Leg Cramps
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin-lichenoid (central chest)
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
66.7%
2/3 • Number of events 5 • Baseline to 2 years
|
33.3%
2/6 • Number of events 3 • Baseline to 2 years
|
25.0%
5/20 • Number of events 5 • Baseline to 2 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Endocrine disorders
Abnormal TSH
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
66.7%
2/3 • Number of events 3 • Baseline to 2 years
|
33.3%
2/6 • Number of events 4 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
66.7%
2/3 • Number of events 3 • Baseline to 2 years
|
33.3%
2/6 • Number of events 3 • Baseline to 2 years
|
10.0%
2/20 • Number of events 2 • Baseline to 2 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 2 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
10.0%
2/20 • Number of events 2 • Baseline to 2 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
66.7%
2/3 • Number of events 4 • Baseline to 2 years
|
33.3%
2/6 • Number of events 2 • Baseline to 2 years
|
20.0%
4/20 • Number of events 4 • Baseline to 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
General disorders
Edema limbs
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 2 • Baseline to 2 years
|
10.0%
2/20 • Number of events 3 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopcia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
15.0%
3/20 • Number of events 7 • Baseline to 2 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Investigations
Asparatate aminotransferase increased
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
45.0%
9/20 • Number of events 17 • Baseline to 2 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic systems disorders
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Eye disorders
Cataract
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
10.0%
2/20 • Number of events 2 • Baseline to 2 years
|
|
Endocrine disorders
Elevated TSH
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 2 • Baseline to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue disorder
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
10.0%
2/20 • Number of events 2 • Baseline to 2 years
|
|
Eye disorders
Congenital retainal pigment epithelial hypertrophy rt. eye
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
100.0%
1/1 • Number of events 1 • Baseline to 2 years
|
100.0%
1/1 • Number of events 1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
33.3%
2/6 • Number of events 4 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
50.0%
3/6 • Number of events 5 • Baseline to 2 years
|
35.0%
7/20 • Number of events 10 • Baseline to 2 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Cardiac disorders
Non-cardiac chest pain
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
10.0%
2/20 • Number of events 2 • Baseline to 2 years
|
|
General disorders
Pain
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
33.3%
2/6 • Number of events 5 • Baseline to 2 years
|
15.0%
3/20 • Number of events 4 • Baseline to 2 years
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 2 • Baseline to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain inextremity
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
15.0%
3/20 • Number of events 5 • Baseline to 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
10.0%
2/20 • Number of events 2 • Baseline to 2 years
|
|
Nervous system disorders
Bilateral peripheral neuropathy
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Eye disorders
Photophobia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
15.0%
3/20 • Number of events 8 • Baseline to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
100.0%
1/1 • Number of events 2 • Baseline to 2 years
|
100.0%
1/1 • Number of events 2 • Baseline to 2 years
|
66.7%
2/3 • Number of events 2 • Baseline to 2 years
|
33.3%
1/3 • Number of events 3 • Baseline to 2 years
|
50.0%
3/6 • Number of events 15 • Baseline to 2 years
|
35.0%
7/20 • Number of events 13 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
100.0%
1/1 • Number of events 1 • Baseline to 2 years
|
100.0%
1/1 • Number of events 1 • Baseline to 2 years
|
66.7%
2/3 • Number of events 2 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
50.0%
3/6 • Number of events 19 • Baseline to 2 years
|
20.0%
4/20 • Number of events 5 • Baseline to 2 years
|
|
Eye disorders
Retinal detachment
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 2 • Baseline to 2 years
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 2 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Eye disorders
Redness in eyes
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Infections and infestations
Pneumonia
|
100.0%
1/1 • Number of events 1 • Baseline to 2 years
|
100.0%
1/1 • Number of events 1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
33.3%
2/6 • Number of events 3 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
2/6 • Number of events 2 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 2 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
15.0%
3/20 • Number of events 5 • Baseline to 2 years
|
|
Eye disorders
Watery eyes
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Investigations
Weight loss
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
66.7%
2/3 • Number of events 5 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Investigations
White blood cell decreased
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
2/6 • Number of events 2 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Infections and infestations
Wound infection
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 2 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Injury, poisoning and procedural complications
Right shoulder injury
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 2 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Investigations
Prothromibn Time prolonged
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Investigations
ALK decreased
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Pain injection site
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 2 • Baseline to 2 years
|
83.3%
5/6 • Number of events 14 • Baseline to 2 years
|
15.0%
3/20 • Number of events 8 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Injection site - redness
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Warmth-Injection site
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
83.3%
5/6 • Number of events 19 • Baseline to 2 years
|
5.0%
1/20 • Number of events 2 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin injection site pruritus
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
15.0%
3/20 • Number of events 8 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin-benign nevi (trunk)
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin-actinic keratosis (left dorsal hand)
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin-lichenoid dermatitis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin redness-lesion
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin-lichenoid reaction
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin-vitiligo
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 4 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Non-inflamed seborrheic keratosis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Lentigines and cherry angioma
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Pigmented macules
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Squamous cell carcinoma in situ
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin Redness
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 4 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Redness tumor injection site
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
2/6 • Number of events 3 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin warmth
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin rash on chest and arm
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Eczematous Eruption
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 3 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Inflamed seborrheic keratosis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
10.0%
2/20 • Number of events 2 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Heat exhaustion
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Injection site pruritus
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
50.0%
3/6 • Number of events 10 • Baseline to 2 years
|
15.0%
3/20 • Number of events 16 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Left axilla pain
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 2 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Left axilla -differential diagnosis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Laparoscopy hernia repair
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Pain-surgical site
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin-Rash, contact dermatitis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
10.0%
2/20 • Number of events 2 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Chondrodermatitis nodularis helicis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Blistering at tape site
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin redness with blisters
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Skin and subcutaneous tissue disorders
Nummular dermatitis - pruritic
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Investigations
Alamine aminotransferase increased
|
100.0%
1/1 • Number of events 1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 2 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
66.7%
4/6 • Number of events 9 • Baseline to 2 years
|
60.0%
12/20 • Number of events 32 • Baseline to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • Number of events 1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 2 • Baseline to 2 years
|
66.7%
2/3 • Number of events 3 • Baseline to 2 years
|
50.0%
3/6 • Number of events 7 • Baseline to 2 years
|
10.0%
2/20 • Number of events 2 • Baseline to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/1 • Baseline to 2 years
|
100.0%
1/1 • Number of events 1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
66.7%
2/3 • Number of events 15 • Baseline to 2 years
|
66.7%
4/6 • Number of events 7 • Baseline to 2 years
|
70.0%
14/20 • Number of events 29 • Baseline to 2 years
|
|
Gastrointestinal disorders
Chelitis
|
0.00%
0/1 • Baseline to 2 years
|
100.0%
1/1 • Number of events 1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 2 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Investigations
Alakaline phosphatase increased
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 2 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
16.7%
1/6 • Number of events 3 • Baseline to 2 years
|
30.0%
6/20 • Number of events 7 • Baseline to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 2 • Baseline to 2 years
|
33.3%
1/3 • Number of events 2 • Baseline to 2 years
|
50.0%
3/6 • Number of events 4 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Injury, poisoning and procedural complications
Brusing
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
15.0%
3/20 • Number of events 4 • Baseline to 2 years
|
|
General disorders
Chills
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
83.3%
5/6 • Number of events 9 • Baseline to 2 years
|
20.0%
4/20 • Number of events 5 • Baseline to 2 years
|
|
Investigations
Creatinine increased
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
66.7%
2/3 • Number of events 7 • Baseline to 2 years
|
83.3%
5/6 • Number of events 10 • Baseline to 2 years
|
45.0%
9/20 • Number of events 19 • Baseline to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 3 • Baseline to 2 years
|
66.7%
2/3 • Number of events 3 • Baseline to 2 years
|
50.0%
3/6 • Number of events 8 • Baseline to 2 years
|
40.0%
8/20 • Number of events 12 • Baseline to 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
33.3%
2/6 • Number of events 4 • Baseline to 2 years
|
15.0%
3/20 • Number of events 4 • Baseline to 2 years
|
|
General disorders
Right lung pain
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Endocrine disorders
Hyperthrodism- elevated TSH
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Infections and infestations
Pruritic rash
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 2 • Baseline to 2 years
|
|
Musculoskeletal and connective tissue disorders
Plantar facitis
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 1 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/6 • Baseline to 2 years
|
5.0%
1/20 • Number of events 1 • Baseline to 2 years
|
|
General disorders
Flu like symptoms
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
16.7%
1/6 • Number of events 1 • Baseline to 2 years
|
35.0%
7/20 • Number of events 18 • Baseline to 2 years
|
|
Vascular disorders
Flushing
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
2/6 • Number of events 2 • Baseline to 2 years
|
0.00%
0/20 • Baseline to 2 years
|
|
General disorders
Fever
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/1 • Baseline to 2 years
|
0.00%
0/3 • Baseline to 2 years
|
33.3%
1/3 • Number of events 2 • Baseline to 2 years
|
50.0%
3/6 • Number of events 7 • Baseline to 2 years
|
30.0%
6/20 • Number of events 10 • Baseline to 2 years
|
|
General disorders
Fatigue
|
0.00%
0/1 • Baseline to 2 years
|
100.0%
1/1 • Baseline to 2 years
|
66.7%
2/3 • Number of events 2 • Baseline to 2 years
|
66.7%
2/3 • Number of events 6 • Baseline to 2 years
|
33.3%
2/6 • Number of events 4 • Baseline to 2 years
|
70.0%
14/20 • Number of events 25 • Baseline to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place