Trial Outcomes & Findings for Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors (NCT NCT04106492)
NCT ID: NCT04106492
Last Updated: 2025-11-14
Results Overview
To determine the Recommended Phase 2 Dose of SQ3370
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
53 participants
Primary outcome timeframe
From start of treatment to approximately 12 weeks
Results posted on
2025-11-14
Participant Flow
Participant milestones
| Measure |
Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33)
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 32 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33)
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 8 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33)
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 16 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33)
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 58 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33)
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 85 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33)
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 125 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33)
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 185 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33)
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33)
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 315 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33)
20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 85 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33)
20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 125 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33)
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 185 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Phase 2a Expansion Group 1 (Extremity STS) (20 mL SQL70 and 250 mg/m^2/Day of SQP33)
20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with soft tissue sarcomas of the extremity
|
P2a Grp 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 Days and and 250 mg/m^2/ of SQP33 for 1 Day)
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 500 mg/m\^2 of SQP33 infused on Day 1 and 2 with 250 mg/m\^2 of SQP33 infused on each Day 3 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve
|
P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days)
10 mL of SQL70 injected intratumorally on Day with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
3
|
3
|
4
|
4
|
7
|
6
|
5
|
3
|
1
|
2
|
6
|
6
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
3
|
3
|
4
|
4
|
7
|
6
|
5
|
3
|
1
|
2
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33)
n=1 Participants
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 8 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33)
n=1 Participants
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 16 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33)
n=1 Participants
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 32 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33)
n=3 Participants
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 58 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33)
n=3 Participants
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 85 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33)
n=4 Participants
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 125 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33)
n=4 Participants
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 185 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33)
n=7 Participants
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33)
n=6 Participants
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 315 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33)
n=5 Participants
20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 85 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33)
n=3 Participants
20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 125 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33)
n=1 Participants
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 185 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Phase 2a Expansion Group 1 (Extremity STS) (20 mL SQL70 and 250 mg/m^2/Day of SQP33)
n=2 Participants
20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with soft tissue sarcomas of the extremity
|
P2a Grp 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 Days and and 250 mg/m^2/ of SQP33 for 1 Day)
n=6 Participants
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 500 mg/m\^2 of SQP33 infused on Day 1 and 2 with 250 mg/m\^2 of SQP33 infused on each Day 3 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve
|
P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days)
n=6 Participants
10 mL of SQL70 injected intratumorally on Day with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=45 Participants
|
2 Participants
n=44 Participants
|
1 Participants
n=45 Participants
|
1 Participants
n=265 Participants
|
3 Participants
n=18 Participants
|
2 Participants
n=15 Participants
|
1 Participants
n=91 Participants
|
3 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
1 Participants
n=49 Participants
|
4 Participants
n=51 Participants
|
4 Participants
n=52 Participants
|
26 Participants
n=101 Participants
|
|
Age, Continuous
|
66 years
n=10 Participants
|
70 years
n=10 Participants
|
47 years
n=20 Participants
|
65 years
n=45 Participants
|
68 years
n=44 Participants
|
44.5 years
n=45 Participants
|
63.5 years
n=265 Participants
|
65 years
n=18 Participants
|
62 years
n=15 Participants
|
63 years
n=91 Participants
|
53 years
n=52 Participants
|
84 years
n=53 Participants
|
45 years
n=49 Participants
|
64 years
n=51 Participants
|
57 years
n=52 Participants
|
58 years
n=101 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
1 Participants
n=44 Participants
|
3 Participants
n=45 Participants
|
3 Participants
n=265 Participants
|
4 Participants
n=18 Participants
|
4 Participants
n=15 Participants
|
4 Participants
n=91 Participants
|
0 Participants
n=52 Participants
|
1 Participants
n=53 Participants
|
1 Participants
n=49 Participants
|
2 Participants
n=51 Participants
|
2 Participants
n=52 Participants
|
27 Participants
n=101 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=45 Participants
|
1 Participants
n=265 Participants
|
3 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=91 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
2 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
1 Participants
n=52 Participants
|
10 Participants
n=101 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=45 Participants
|
3 Participants
n=44 Participants
|
3 Participants
n=45 Participants
|
3 Participants
n=265 Participants
|
4 Participants
n=18 Participants
|
6 Participants
n=15 Participants
|
3 Participants
n=91 Participants
|
3 Participants
n=52 Participants
|
1 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
6 Participants
n=51 Participants
|
5 Participants
n=52 Participants
|
43 Participants
n=101 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=91 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=101 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=91 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=101 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=91 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
2 Participants
n=51 Participants
|
0 Participants
n=52 Participants
|
6 Participants
n=101 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=91 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=101 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=91 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=101 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=45 Participants
|
1 Participants
n=44 Participants
|
4 Participants
n=45 Participants
|
4 Participants
n=265 Participants
|
6 Participants
n=18 Participants
|
5 Participants
n=15 Participants
|
4 Participants
n=91 Participants
|
3 Participants
n=52 Participants
|
1 Participants
n=53 Participants
|
2 Participants
n=49 Participants
|
4 Participants
n=51 Participants
|
5 Participants
n=52 Participants
|
45 Participants
n=101 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=91 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=101 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=91 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
1 Participants
n=52 Participants
|
2 Participants
n=101 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=10 Participants
|
0 participants
n=10 Participants
|
1 participants
n=20 Participants
|
1 participants
n=45 Participants
|
1 participants
n=44 Participants
|
2 participants
n=45 Participants
|
3 participants
n=265 Participants
|
6 participants
n=18 Participants
|
5 participants
n=15 Participants
|
5 participants
n=91 Participants
|
3 participants
n=52 Participants
|
1 participants
n=53 Participants
|
2 participants
n=49 Participants
|
6 participants
n=51 Participants
|
5 participants
n=52 Participants
|
42 participants
n=101 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=10 Participants
|
1 participants
n=10 Participants
|
0 participants
n=20 Participants
|
2 participants
n=45 Participants
|
2 participants
n=44 Participants
|
2 participants
n=45 Participants
|
1 participants
n=265 Participants
|
1 participants
n=18 Participants
|
1 participants
n=15 Participants
|
0 participants
n=91 Participants
|
0 participants
n=52 Participants
|
0 participants
n=53 Participants
|
0 participants
n=49 Participants
|
0 participants
n=51 Participants
|
1 participants
n=52 Participants
|
11 participants
n=101 Participants
|
|
Prior exposure to anthracyclines
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=45 Participants
|
2 Participants
n=44 Participants
|
1 Participants
n=45 Participants
|
2 Participants
n=265 Participants
|
3 Participants
n=18 Participants
|
1 Participants
n=15 Participants
|
4 Participants
n=91 Participants
|
3 Participants
n=52 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=52 Participants
|
19 Participants
n=101 Participants
|
PRIMARY outcome
Timeframe: From start of treatment to approximately 12 weeksPopulation: Dose escalation participants
To determine the Recommended Phase 2 Dose of SQ3370
Outcome measures
| Measure |
Dose Escalation Cohort (10 mL SQL70)
n=30 Participants
Participants will receive 10 mL of SQL70 biopolymer injected intratumorally on Day 1 of each 21-day cycle into a single lesion and then receive escalating doses of SQP33 protodrug administered IV from Day 1 through Day 5 (5 doses) of each 21-day cycle.
SQ3370: SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin
|
Dose Escalation Cohort (20 mL SQL70)
n=8 Participants
Participants will receive 20 mL of SQL70 biopolymer injected intratumorally on Day 1 of each 21-day cycle into a single lesion and then receive escalating doses of SQP33 protodrug administered IV from Day 1 through Day 5 (5 doses) of each 21-day cycle.
SQ3370: SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin
|
P2a Grp 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 Days and and 250 mg/m^2/ of SQP33 for 1 Day)
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 500 mg/m\^2 of SQP33 infused on Day 1 and 2 with 250 mg/m\^2 of SQP33 infused on each Day 3 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve
|
P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days)
10 mL of SQL70 injected intratumorally on Day with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve
|
|---|---|---|---|---|
|
Phase 1 Cohorts
|
1250 mg/m2 per cycle
|
1250 mg/m2 per cycle
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Dose Escalation Cohort (10 mL SQL70)
n=1 Participants
Participants will receive 10 mL of SQL70 biopolymer injected intratumorally on Day 1 of each 21-day cycle into a single lesion and then receive escalating doses of SQP33 protodrug administered IV from Day 1 through Day 5 (5 doses) of each 21-day cycle.
SQ3370: SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin
|
Dose Escalation Cohort (20 mL SQL70)
n=2 Participants
Participants will receive 20 mL of SQL70 biopolymer injected intratumorally on Day 1 of each 21-day cycle into a single lesion and then receive escalating doses of SQP33 protodrug administered IV from Day 1 through Day 5 (5 doses) of each 21-day cycle.
SQ3370: SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin
|
P2a Grp 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 Days and and 250 mg/m^2/ of SQP33 for 1 Day)
n=6 Participants
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 500 mg/m\^2 of SQP33 infused on Day 1 and 2 with 250 mg/m\^2 of SQP33 infused on each Day 3 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve
|
P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days)
n=6 Participants
10 mL of SQL70 injected intratumorally on Day with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve
|
|---|---|---|---|---|
|
Phase 2a: Objective Response Rate (ORR)
|
0 participants with an objective response
|
1 participants with an objective response
|
0 participants with an objective response
|
1 participants with an objective response
|
Adverse Events
Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 2a Expansion Group 1 (Extremity STS) (20 mL SQL70 and 250 mg/m^2/Day of SQP33)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
P2a Grp 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 Days and and 250 mg/m^2/ of SQP33 for 1 Day)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33)
n=1 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 8 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33)
n=1 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 16 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33)
n=1 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 32 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33)
n=3 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 58 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33)
n=3 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 85 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33)
n=4 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 125 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33)
n=4 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 185 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33)
n=7 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33)
n=6 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 315 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33)
n=5 participants at risk
20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 85 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33)
n=3 participants at risk
20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 125 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33)
n=1 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 185 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Phase 2a Expansion Group 1 (Extremity STS) (20 mL SQL70 and 250 mg/m^2/Day of SQP33)
n=2 participants at risk
20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with soft tissue sarcomas of the extremity
|
P2a Grp 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 Days and and 250 mg/m^2/ of SQP33 for 1 Day)
n=6 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 500 mg/m\^2 of SQP33 infused on Day 1 and 2 with 250 mg/m\^2 of SQP33 infused on each Day 3 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve
|
P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days)
n=6 participants at risk
10 mL of SQL70 injected intratumorally on Day with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
28.6%
2/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
100.0%
1/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
50.0%
2/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Device related infection
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
General physical health deterioration
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
16.7%
1/6 • 1 year
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
28.6%
2/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Investigations
Troponin T increased
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Urosepsis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Investigations
Prohormone brain natriuretic peptide increased
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Pyrexia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Chills
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
Other adverse events
| Measure |
Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33)
n=1 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 8 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33)
n=1 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 16 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33)
n=1 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 32 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33)
n=3 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 58 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33)
n=3 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 85 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33)
n=4 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 125 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33)
n=4 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 185 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33)
n=7 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33)
n=6 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 315 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33)
n=5 participants at risk
20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 85 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33)
n=3 participants at risk
20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 125 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33)
n=1 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 185 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
|
Phase 2a Expansion Group 1 (Extremity STS) (20 mL SQL70 and 250 mg/m^2/Day of SQP33)
n=2 participants at risk
20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with soft tissue sarcomas of the extremity
|
P2a Grp 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 Days and and 250 mg/m^2/ of SQP33 for 1 Day)
n=6 participants at risk
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 500 mg/m\^2 of SQP33 infused on Day 1 and 2 with 250 mg/m\^2 of SQP33 infused on each Day 3 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve
|
P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days)
n=6 participants at risk
10 mL of SQL70 injected intratumorally on Day with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Medical Device Site Pain
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Peripheral Swelling
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
16.7%
1/6 • 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
25.0%
1/4 • 1 year
|
50.0%
2/4 • 1 year
|
14.3%
1/7 • 1 year
|
16.7%
1/6 • 1 year
|
80.0%
4/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
16.7%
1/6 • 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
28.6%
2/7 • 1 year
|
0.00%
0/6 • 1 year
|
40.0%
2/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
50.0%
1/2 • 1 year
|
16.7%
1/6 • 1 year
|
33.3%
2/6 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
28.6%
2/7 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
16.7%
1/6 • 1 year
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
42.9%
3/7 • 1 year
|
50.0%
3/6 • 1 year
|
40.0%
2/5 • 1 year
|
66.7%
2/3 • 1 year
|
0.00%
0/1 • 1 year
|
50.0%
1/2 • 1 year
|
0.00%
0/6 • 1 year
|
16.7%
1/6 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
33.3%
2/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
50.0%
2/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
100.0%
1/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
100.0%
1/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Covid-19
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
50.0%
2/4 • 1 year
|
42.9%
3/7 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
33.3%
2/6 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
14.3%
1/7 • 1 year
|
16.7%
1/6 • 1 year
|
40.0%
2/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
33.3%
2/6 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
50.0%
3/6 • 1 year
|
33.3%
2/6 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
16.7%
1/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Colonic Fistula
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
50.0%
1/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Lip Pain
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Fatigue
|
100.0%
1/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • 1 year
|
100.0%
3/3 • 1 year
|
33.3%
1/3 • 1 year
|
25.0%
1/4 • 1 year
|
25.0%
1/4 • 1 year
|
42.9%
3/7 • 1 year
|
66.7%
4/6 • 1 year
|
20.0%
1/5 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
2/2 • 1 year
|
33.3%
2/6 • 1 year
|
66.7%
4/6 • 1 year
|
|
General disorders
Pyrexia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
66.7%
2/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
28.6%
2/7 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Chills
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
42.9%
3/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Oedema Peripheral
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • 1 year
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
50.0%
1/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Pain
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Catheter Site Erythema
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Face Oedema
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Impaired Healing
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Injection Site Bruising
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Injection Site Erythema
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Injection Site Pain
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
33.3%
2/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Medical Device Site Infection
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Skin Infection
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Urosepsis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Vascular Access Site Infection
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
33.3%
2/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
16.7%
1/6 • 1 year
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
28.6%
2/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
50.0%
2/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Candida Infection
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
50.0%
1/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
16.7%
1/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
14.3%
1/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
50.0%
1/2 • 1 year
|
16.7%
1/6 • 1 year
|
16.7%
1/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Displacement
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
14.3%
1/7 • 1 year
|
50.0%
3/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
33.3%
2/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
14.3%
1/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
50.0%
1/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
16.7%
1/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
16.7%
1/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Reproductive system and breast disorders
Breast Pain
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
16.7%
1/6 • 1 year
|
|
Endocrine disorders
Inappropriate Antidiuretic Hormone Secretion
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
16.7%
1/6 • 1 year
|
|
Eye disorders
Blindness Transient
|
100.0%
1/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Eye disorders
Diplopia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Eye disorders
Dry Eye
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
33.3%
2/6 • 1 year
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Renal and urinary disorders
Bladder Spasm
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Renal and urinary disorders
Urge Incontinence
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
16.7%
1/6 • 1 year
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
33.3%
2/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Psychiatric disorders
Delirium
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
20.0%
1/5 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
16.7%
1/6 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
100.0%
1/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
50.0%
3/6 • 1 year
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
50.0%
2/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Nervous system disorders
Haemorrhagic Transformation Stroke
|
100.0%
1/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Nervous system disorders
Lethargy
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Vascular disorders
Pelvic Venous Thrombosis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Vascular disorders
Hot Flush
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Vascular disorders
Phlebitis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
50.0%
2/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/7 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular Access Site Erythema
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Vascular disorders
Vascular Access Site Haematoma
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
14.3%
1/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Vascular disorders
Limb Injury
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Vascular disorders
Post Procedural Discharge
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
16.7%
1/6 • 1 year
|
|
Vascular disorders
Vascular Access Site Pain
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
50.0%
1/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
50.0%
2/4 • 1 year
|
28.6%
2/7 • 1 year
|
16.7%
1/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
50.0%
1/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • 1 year
|
100.0%
1/1 • 1 year
|
66.7%
2/3 • 1 year
|
66.7%
2/3 • 1 year
|
75.0%
3/4 • 1 year
|
25.0%
1/4 • 1 year
|
57.1%
4/7 • 1 year
|
50.0%
3/6 • 1 year
|
40.0%
2/5 • 1 year
|
66.7%
2/3 • 1 year
|
0.00%
0/1 • 1 year
|
50.0%
1/2 • 1 year
|
83.3%
5/6 • 1 year
|
100.0%
6/6 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
25.0%
1/4 • 1 year
|
28.6%
2/7 • 1 year
|
33.3%
2/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/2 • 1 year
|
50.0%
3/6 • 1 year
|
16.7%
1/6 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place