Trial Outcomes & Findings for Axalimogene Filolisbac (ADXS11-001) High Dose in Women With Human Papillomavirus (HPV) + Cervical Cancer (NCT NCT02164461)
NCT ID: NCT02164461
Last Updated: 2024-05-20
Results Overview
DLT was defined as occurrence of any of the following toxicities that are possibly, probably or definitely related to therapy. Hematologic: 1. Grade 4 hematologic toxicity. 2. Febrile neutropenia, defined as absolute neutrophil count (ANC) \< 1000/mm\^3 with a single temperature of \>38.3° C (101° F) or a sustained temperature of \>38° C (100.4° F) for more than 1 hour. 3. Grade 3 thrombocytopenia lasting \>72 hours. 4. Grade 4 thrombocytopenia. Non-Hematologic: 1. ≥Grade 3 non-hematologic toxicity 2. Grade 3 non hematologic laboratory values. 3. Listeremia: positive blood cultures along with persistent (for 72 hours post dose) symptoms consistent with listeremia (e.g., fever and muscle aches, often preceded by diarrhea or other gastrointestinal symptoms). 4. ≥Grade 3 flu-like symptoms or cytokine release symptoms that persist for \>24 hours after study treatment administration despite symptomatic treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Up to 28 days in Cycle 1 (12 weeks cycle)
Results posted on
2024-05-20
Participant Flow
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy were enrolled in this study.
Participants received a prophylactic regimen that was completed prior to each axalimogene filolisbac infusion to mitigate and manage potential immune responses seen with immunotherapy administration.
Participant milestones
| Measure |
Axalimogene Filolisbac 1x10^9 Cfu
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^9 colony forming units (cfu) by intravenous infusion, over 60 minutes duration, every 3 weeks (Q3W) in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 5x10^9 Cfu
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 5x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 1x10^10 Cfu
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^10 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
6
|
5
|
|
Overall Study
Enrolled Participants
|
0
|
6
|
6
|
|
Overall Study
Treated Participants
|
1
|
6
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
5
|
Reasons for withdrawal
| Measure |
Axalimogene Filolisbac 1x10^9 Cfu
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^9 colony forming units (cfu) by intravenous infusion, over 60 minutes duration, every 3 weeks (Q3W) in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 5x10^9 Cfu
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 5x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 1x10^10 Cfu
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^10 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Disease Progression
|
1
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
0
|
Baseline Characteristics
Axalimogene Filolisbac (ADXS11-001) High Dose in Women With Human Papillomavirus (HPV) + Cervical Cancer
Baseline characteristics by cohort
| Measure |
Axalimogene Filolisbac 5x10^9 Cfu
n=6 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 5x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 1x10^9 Cfu
n=1 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 1x10^10 Cfu
n=5 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^10 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 11.22 • n=7 Participants
|
39.0 years
n=5 Participants
|
59.2 years
STANDARD_DEVIATION 19.10 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 15.04 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days in Cycle 1 (12 weeks cycle)Population: All Treated Participants
DLT was defined as occurrence of any of the following toxicities that are possibly, probably or definitely related to therapy. Hematologic: 1. Grade 4 hematologic toxicity. 2. Febrile neutropenia, defined as absolute neutrophil count (ANC) \< 1000/mm\^3 with a single temperature of \>38.3° C (101° F) or a sustained temperature of \>38° C (100.4° F) for more than 1 hour. 3. Grade 3 thrombocytopenia lasting \>72 hours. 4. Grade 4 thrombocytopenia. Non-Hematologic: 1. ≥Grade 3 non-hematologic toxicity 2. Grade 3 non hematologic laboratory values. 3. Listeremia: positive blood cultures along with persistent (for 72 hours post dose) symptoms consistent with listeremia (e.g., fever and muscle aches, often preceded by diarrhea or other gastrointestinal symptoms). 4. ≥Grade 3 flu-like symptoms or cytokine release symptoms that persist for \>24 hours after study treatment administration despite symptomatic treatment.
Outcome measures
| Measure |
Axalimogene Filolisbac 1x10^9 Cfu
n=1 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 5x10^9 Cfu
n=6 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 5x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 1x10^10 Cfu
n=5 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^10 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 120 days post dosePopulation: All Treated Participants
Number of participants with delayed listeria infection was reported.
Outcome measures
| Measure |
Axalimogene Filolisbac 1x10^9 Cfu
n=1 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 5x10^9 Cfu
n=6 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 5x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 1x10^10 Cfu
n=5 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^10 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
|---|---|---|---|
|
Listeria Monocytogenes Surveillance
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From first dose up to 2.3 yearsPopulation: All Treated Participants
Adverse event (AE): any untoward medical occurrence in a participant administered a study treatment \& which did not necessarily have to have a causal relationship with the study treatment. An AE is, any unfavorable \& unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of study treatment. AE with onset on or after the date of first administration of the study treatment until the end of the Listeria Monocytogenes (Lm) surveillance period.
Outcome measures
| Measure |
Axalimogene Filolisbac 1x10^9 Cfu
n=1 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 5x10^9 Cfu
n=6 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 5x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 1x10^10 Cfu
n=5 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^10 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
1 Participants
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From first dose until end of treatment (Maximum duration: 1.5 years)Population: All Treated Participants
ORR as per RECIST 1.1 was defined as the percentage of participants who achieved complete response (CR) or partial response (PR). CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions.
Outcome measures
| Measure |
Axalimogene Filolisbac 1x10^9 Cfu
n=1 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 5x10^9 Cfu
n=6 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 5x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 1x10^10 Cfu
n=5 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^10 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
|---|---|---|---|
|
Objective Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
0.00 percentage of participants
Interval 0.0 to 97.5
|
0.00 percentage of participants
Interval 0.0 to 45.93
|
20.00 percentage of participants
Interval 0.51 to 71.64
|
SECONDARY outcome
Timeframe: From first objective response to disease progression or death (Maximum duration: 1.5 years)Population: All Treated Participants
Duration of response as per RECIST 1.1 was defined as the time interval from CR or PR to disease progression or death. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Progressive disease (PD) was defined as at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. The appearance of one or more new lesions is also considered progression .Kaplan-Meier method was used to estimate median and 95% confidence interval (CI).
Outcome measures
| Measure |
Axalimogene Filolisbac 1x10^9 Cfu
n=1 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 5x10^9 Cfu
n=6 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 5x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 1x10^10 Cfu
n=5 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^10 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
|---|---|---|---|
|
Duration of Tumor Response as Per RECIST 1.1
|
NA days
Median and 95% CI was not estimable as there were no events
|
NA days
Median and 95% CI was not estimable as there were no events
|
269.0 days
95% CI was not estimable due to low number of events
|
SECONDARY outcome
Timeframe: From study enrollment to disease progression or death (Maximum duration: 1.5 years)Population: All Treated Participants
PFS as per RECIST 1.1 was defined as the time interval from study enrollment to disease progression or death. Participants who were alive with no disease progression were censored at the date of the last tumor assessment. PD was defined as at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. The appearance of one or more new lesions is also considered progression.The Kaplan-Meier method was used to estimate median and 95% CI.
Outcome measures
| Measure |
Axalimogene Filolisbac 1x10^9 Cfu
n=1 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 5x10^9 Cfu
n=6 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 5x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 1x10^10 Cfu
n=5 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^10 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
|---|---|---|---|
|
Progression Free Survival (PFS) as Per RECIST 1.1
|
124.0 days
95% CI was not estimable due to low number of events
|
85.0 days
Interval 80.0 to 99.0
|
176.5 days
Interval 78.0 to 528.0
|
SECONDARY outcome
Timeframe: From first dose until end of treatment (Maximum duration was 1.5 years)Population: All Treated Participants
ORR as per irRECIST was defined as the percent of participants who achieved immune response complete response (irCR) or immune response partial response (irPR). irCR was defined as disappearance of all lesions. irPR was defined as ≥30% decrease in tumor burden compared with baseline.
Outcome measures
| Measure |
Axalimogene Filolisbac 1x10^9 Cfu
n=1 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 5x10^9 Cfu
n=6 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 5x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 1x10^10 Cfu
n=5 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^10 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
|---|---|---|---|
|
ORR as Per Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
|
0.00 percentage of participants
Interval 0.0 to 97.5
|
0.00 percentage of participants
Interval 0.0 to 45.93
|
20.00 percentage of participants
Interval 0.51 to 71.64
|
SECONDARY outcome
Timeframe: From first objective response to disease progression or death (Maximum duration: 1.5 years)Population: All Treated Participants
Duration of response as per irRECIST 1.1 was defined as the time interval from irCR or irPR to disease progression or death. irCR was defined as disappearance of all lesions. irPR was defined as ≥30% decrease in tumor burden compared with baseline. Immune response progressive disease (irPD) was defined as at least 20% increase in tumor burden compared with nadir (at any single time point). The Kaplan-Meier method was used to estimate median and 95% CI.
Outcome measures
| Measure |
Axalimogene Filolisbac 1x10^9 Cfu
n=1 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 5x10^9 Cfu
n=6 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 5x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 1x10^10 Cfu
n=5 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^10 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
|---|---|---|---|
|
Duration of Tumor Response as Per irRECIST
|
NA days
Median and 95% CI was not estimable as there were no events
|
NA days
Median and 95% CI was not estimable as there were no events
|
269.0 days
95% CI was not estimable due to low number of events
|
SECONDARY outcome
Timeframe: From study enrollment to disease progression or death (Maximum duration: 1.5 years)Population: All Treated Participants
PFS as per irRECIST 1.1 was defined as the time interval from study enrollment to disease progression or death. Participants who were alive with no disease progression were censored at the date of the last tumor assessment. irPD was defined as at least 20% increase in tumor burden compared with nadir (at any single time point). The Kaplan-Meier method was used to estimate median and 95% CI.
Outcome measures
| Measure |
Axalimogene Filolisbac 1x10^9 Cfu
n=1 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 5x10^9 Cfu
n=6 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 5x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 1x10^10 Cfu
n=5 Participants
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^10 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
|---|---|---|---|
|
PFS as Per irRECIST
|
124.0 days
95% CI was not estimable due to low number of events
|
85.0 days
Interval 80.0 to 99.0
|
176.5 days
Interval 78.0 to 528.0
|
Adverse Events
Axalimogene Filolisbac 1x10^9 Cfu
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Axalimogene Filolisbac 5x10^9 Cfu
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Axalimogene Filolisbac 1x10^10 Cfu
Serious events: 1 serious events
Other events: 5 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Axalimogene Filolisbac 1x10^9 Cfu
n=1 participants at risk
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 5x10^9 Cfu
n=6 participants at risk
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 5x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 1x10^10 Cfu
n=5 participants at risk
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^10 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
|---|---|---|---|
|
Vascular disorders
Hypotension
|
100.0%
1/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Vascular disorders
Embolism
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
Other adverse events
| Measure |
Axalimogene Filolisbac 1x10^9 Cfu
n=1 participants at risk
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 5x10^9 Cfu
n=6 participants at risk
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 5x10\^9 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
Axalimogene Filolisbac 1x10^10 Cfu
n=5 participants at risk
Participants with persistent, metastatic, or recurrent carcinoma of the cervix who failed conventional therapy received axalimogene filolisbac at dose of 1x10\^10 cfu by intravenous infusion, over 60 minutes duration, Q3W in repeating 12-week treatment cycles (Day 1 of Weeks 1, 4, 7, and 10 of each cycle) until a discontinuation criterion was met. Participants received a 7-day course of oral antibiotic therapy starting approximately 72 hours (Day 4) after each administration of axalimogene filolisbac. Antibiotic therapy consisted of trimethoprim (80 mg)/sulfamethoxazole (400 mg) tablets (Bactrim) or trimethoprim (160 mg)/ sulfamethoxazole (800 mg) tablets (Bactrim DS), administered 3 times during the 7 consecutive days or ampicillin 500 mg 4 times daily for 7 consecutive days for participants with sulfa allergy.
|
|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
100.0%
1/1 • 2 years and 3 days.
All Treated Participants
|
33.3%
2/6 • 2 years and 3 days.
All Treated Participants
|
40.0%
2/5 • 2 years and 3 days.
All Treated Participants
|
|
General disorders
Pyrexia
|
100.0%
1/1 • 2 years and 3 days.
All Treated Participants
|
33.3%
2/6 • 2 years and 3 days.
All Treated Participants
|
80.0%
4/5 • 2 years and 3 days.
All Treated Participants
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
100.0%
1/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Vascular disorders
Hypotension
|
100.0%
1/1 • 2 years and 3 days.
All Treated Participants
|
66.7%
4/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
50.0%
3/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
33.3%
2/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
50.0%
3/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
50.0%
3/6 • 2 years and 3 days.
All Treated Participants
|
40.0%
2/5 • 2 years and 3 days.
All Treated Participants
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
33.3%
2/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
33.3%
2/6 • 2 years and 3 days.
All Treated Participants
|
60.0%
3/5 • 2 years and 3 days.
All Treated Participants
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
40.0%
2/5 • 2 years and 3 days.
All Treated Participants
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
General disorders
Chills
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
66.7%
4/6 • 2 years and 3 days.
All Treated Participants
|
60.0%
3/5 • 2 years and 3 days.
All Treated Participants
|
|
General disorders
Malaise
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
33.3%
2/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Infections and infestations
Candida infection
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
40.0%
2/5 • 2 years and 3 days.
All Treated Participants
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
33.3%
2/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
33.3%
2/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Investigations
Capillary nail refill test abnormal
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Investigations
Skin turgor decreased
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
40.0%
2/5 • 2 years and 3 days.
All Treated Participants
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
33.3%
2/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
33.3%
2/6 • 2 years and 3 days.
All Treated Participants
|
40.0%
2/5 • 2 years and 3 days.
All Treated Participants
|
|
Nervous system disorders
Aura
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Reproductive system and breast disorders
Pelvic pain
|
100.0%
1/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/5 • 2 years and 3 days.
All Treated Participants
|
|
Vascular disorders
Embolism
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
16.7%
1/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
General disorders
Pain
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
60.0%
3/5 • 2 years and 3 days.
All Treated Participants
|
|
General disorders
Fatigue
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
40.0%
2/5 • 2 years and 3 days.
All Treated Participants
|
|
General disorders
Catheter site pain
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Infections and infestations
Device related infection
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Infections and infestations
Rhinitis
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Investigations
Blood pressure increased
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Investigations
Listeria test positive
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
40.0%
2/5 • 2 years and 3 days.
All Treated Participants
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
40.0%
2/5 • 2 years and 3 days.
All Treated Participants
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • 2 years and 3 days.
All Treated Participants
|
0.00%
0/6 • 2 years and 3 days.
All Treated Participants
|
20.0%
1/5 • 2 years and 3 days.
All Treated Participants
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator shall seek the Sponsor's written approval for study results publication which shall not be unreasonably withheld. Such publication by Institution and/or Investigator may be no earlier than after a cooperative publication has been published with Sponsor or 1 year from date of completion or termination of the Study \& only after review and comment by Sponsor. Institution agrees to provide Sponsor a copy of proposed publication at least 60 days prior to submission to a publisher.
- Publication restrictions are in place
Restriction type: OTHER