Trial Outcomes & Findings for Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma (NCT NCT03710876)
NCT ID: NCT03710876
Last Updated: 2025-05-20
Results Overview
Time to death (from any cause) from randomization
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
53 participants
Primary outcome timeframe
4 years and 8 months
Results posted on
2025-05-20
Participant Flow
The study opened to recruitment in January 2019 and was scheduled to complete recruitment by May 2021, with a target of approximately 300. 53 patients were randomized to treatment.
Participant milestones
| Measure |
Treatment Group
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\]
rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
Control Group
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET.
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
|
Overall Study
Treated
|
27
|
22
|
|
Overall Study
COMPLETED
|
27
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
| Measure |
Treatment Group
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\]
rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
Control Group
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET.
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
|---|---|---|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma
Baseline characteristics by cohort
| Measure |
Treatment Group
n=27 Participants
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\]
rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
Control Group
n=26 Participants
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET.
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Continuous
|
72.5 Years
STANDARD_DEVIATION 8.84 • n=5 Participants
|
69.3 Years
STANDARD_DEVIATION 10.08 • n=7 Participants
|
70.9 Years
STANDARD_DEVIATION 9.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
France
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Overall Number of Baseline Participants
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 years and 8 monthsPopulation: The Full Analysis Set, which comprised all patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).
Time to death (from any cause) from randomization
Outcome measures
| Measure |
Treatment Group
n=27 Participants
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\]
rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
Control Group
n=22 Participants
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET.
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
|---|---|---|
|
Overall Survival
|
17.6 Months
Interval 8.3 to 31.8
|
15.5 Months
Interval 9.2 to 16.6
|
SECONDARY outcome
Timeframe: 4 years and 8 monthsPopulation: The Full Analysis Set, which comprised all patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).
Time measured in months, from randomization to the time when the modified Response Evaluation Criteria in Solid Tumour criteria for disease progression are first met, or when death from any cause occurs
Outcome measures
| Measure |
Treatment Group
n=27 Participants
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\]
rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
Control Group
n=22 Participants
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET.
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
|---|---|---|
|
Progression Free Survival
|
7.4 Months
Interval 4.1 to 14.2
|
14.6 Months
Interval 4.1 to 15.8
|
SECONDARY outcome
Timeframe: 4 years and 8 monthsPopulation: The Full Analysis Set, which comprised all patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).
Best overall response (BOR) was defined as the best response designation, in the order of Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), or Not Evaluable (NE), for each patient that was recorded between the date of randomization and the date of documented disease progression per mRECIST or mRECIST version 1.1, or the date of subsequent anticancer therapy or cancer-related surgery (i.e., surgical resection of tumour), whichever occurred first. ORR was defined as the proportion of patients with a BOR of CR or PR.
Outcome measures
| Measure |
Treatment Group
n=27 Participants
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\]
rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
Control Group
n=22 Participants
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET.
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
|---|---|---|
|
Best Response: Objective Response Rate (ORR)
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 4 years and 8 monthsPopulation: The Full Analysis Set, which comprised all patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).
Disease control rate (DCR) was defined as the proportion of patients with a BOR of CR, PR, or Stable Disease (SD).
Outcome measures
| Measure |
Treatment Group
n=27 Participants
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\]
rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
Control Group
n=22 Participants
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET.
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
|---|---|---|
|
Best Response: Disease Control Rate (DCR)
|
19 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 4 years and 8 monthsPopulation: The Full Analysis Set, which comprised all patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).
Clinical Benefit Rate (CBR) was defined as the proportion of patients with a BOR of CR, PR, or SD \>/= 6 months.
Outcome measures
| Measure |
Treatment Group
n=27 Participants
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\]
rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
Control Group
n=22 Participants
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET.
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
|---|---|---|
|
Best Response: Clinical Benefit Rate (CBR)
|
9 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: The Full Analysis Set, which comprised all patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).
Proportion surviving at 12 months
Outcome measures
| Measure |
Treatment Group
n=27 Participants
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\]
rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
Control Group
n=22 Participants
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET.
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
|---|---|---|
|
Survival Rate at 12 Months
|
59.3 Percentage of survivors
Interval 38.6 to 75.0
|
63.6 Percentage of survivors
Interval 40.3 to 79.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsPopulation: The Full Analysis Set, which comprised all patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).
Proportion surviving at 18 months
Outcome measures
| Measure |
Treatment Group
n=27 Participants
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\]
rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
Control Group
n=22 Participants
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET.
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
|---|---|---|
|
Survival Rate at 18 Months
|
48.1 Percentage of survivors
Interval 28.7 to 65.2
|
29.8 Percentage of survivors
Interval 12.4 to 49.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsPopulation: The Full Analysis Set, which comprised all patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).
Proportion surviving at 24 months
Outcome measures
| Measure |
Treatment Group
n=27 Participants
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\]
rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
Control Group
n=22 Participants
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET.
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
|---|---|---|
|
Survival Rate at 24 Months
|
37.0 Percentage of survivors
Interval 19.6 to 54.6
|
24.8 Percentage of survivors
Interval 9.2 to 44.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 monthsPopulation: The Full Analysis Set, which comprised all patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).
Proportion surviving at 30 months
Outcome measures
| Measure |
Treatment Group
n=27 Participants
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\]
rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
Control Group
n=22 Participants
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET.
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
|---|---|---|
|
Survival Rate at 30 Months
|
33.3 Percentage of survivors
Interval 16.8 to 50.9
|
19.8 Percentage of survivors
Interval 6.3 to 38.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 monthsPopulation: The Full Analysis Set, which comprised all patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).
Proportion surviving at 36 months
Outcome measures
| Measure |
Treatment Group
n=27 Participants
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\]
rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
Control Group
n=22 Participants
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET.
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
|---|---|---|
|
Survival Rate at 36 Months
|
25.9 Percentage of survivors
Interval 11.5 to 43.1
|
19.8 Percentage of survivors
Interval 6.3 to 38.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 42 monthsPopulation: The Full Analysis Set, which comprised all patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).
Proportion surviving at 42 months
Outcome measures
| Measure |
Treatment Group
n=27 Participants
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\]
rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
Control Group
n=22 Participants
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET.
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
|---|---|---|
|
Survival Rate at 42 Months
|
25.9 Percentage of survivors
Interval 11.5 to 43.1
|
19.8 Percentage of survivors
Interval 6.3 to 38.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 years and 8 months.Population: Safety Analysis Set
To evaluate the number of patients with Common Terminology Criteria for Adverse Events Grade 3 or 4.
Outcome measures
| Measure |
Treatment Group
n=27 Participants
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\]
rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
Control Group
n=22 Participants
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET.
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
|---|---|---|
|
Adverse Events Grade 3 or 4.
|
18 Participants
|
17 Participants
|
Adverse Events
Treatment Group
Serious events: 10 serious events
Other events: 27 other events
Deaths: 22 deaths
Control Group
Serious events: 12 serious events
Other events: 22 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Treatment Group
n=27 participants at risk
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\]
rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
Control Group
n=22 participants at risk
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET.
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/27 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Infections and infestations
Pneumonia
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 4 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Infections and infestations
Sepsis
|
7.4%
2/27 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.4%
2/27 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Cardiac disorders
Cardiac failure
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Vascular disorders
Hypertension
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Infections and infestations
Infection
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Infections and infestations
Clostridium difficile infection
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/27 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Infections and infestations
Pleural infection
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/27 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.4%
2/27 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/27 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary opedema
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
General disorders
Pyrexia
|
11.1%
3/27 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
General disorders
Malaise
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/27 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/27 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/27 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Immune system disorders
Cytokine release syndrome
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Injury, poisoning and procedural complications
Spinal cord injury thoracic
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/27 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/27 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
Other adverse events
| Measure |
Treatment Group
n=27 participants at risk
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\]
rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
Control Group
n=22 participants at risk
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET.
Celecoxib Oral Product: 400 mg twice daily
Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
|
|---|---|---|
|
General disorders
Fatigue
|
40.7%
11/27 • Number of events 27 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
36.4%
8/22 • Number of events 20 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
General disorders
Pyrexia
|
14.8%
4/27 • Number of events 7 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
27.3%
6/22 • Number of events 12 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
General disorders
Asthenia
|
29.6%
8/27 • Number of events 27 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
18.2%
4/22 • Number of events 5 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
General disorders
Oedema peripheral
|
22.2%
6/27 • Number of events 8 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
22.7%
5/22 • Number of events 9 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
General disorders
Non-cardiac chest pain
|
11.1%
3/27 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
General disorders
Chest pain
|
7.4%
2/27 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
General disorders
Malaise
|
0.00%
0/27 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
General disorders
Cather site extravasation
|
7.4%
2/27 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
29.6%
8/27 • Number of events 16 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
36.4%
8/22 • Number of events 10 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.8%
4/27 • Number of events 4 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
13.6%
3/22 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
13.6%
3/22 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
11.1%
3/27 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
7.4%
2/27 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Blood and lymphatic system disorders
Anaemia
|
40.7%
11/27 • Number of events 34 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
40.9%
9/22 • Number of events 18 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.5%
5/27 • Number of events 10 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
27.3%
6/22 • Number of events 17 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
3/27 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 4 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.4%
2/27 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
7.4%
2/27 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Gastrointestinal disorders
Nausea
|
63.0%
17/27 • Number of events 39 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
31.8%
7/22 • Number of events 12 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Gastrointestinal disorders
Constipation
|
14.8%
4/27 • Number of events 4 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
27.3%
6/22 • Number of events 7 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
6/27 • Number of events 8 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
2/27 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
3/27 • Number of events 7 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Gastrointestinal disorders
Abdominal distention
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Gastrointestinal disorders
Dyspep[sia
|
7.4%
2/27 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Gastrointestinal disorders
Stomatitis
|
7.4%
2/27 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
3/27 • Number of events 5 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
13.6%
3/22 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Investigations
Aspartate aminotransferase increased
|
14.8%
4/27 • Number of events 5 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Investigations
Neutrophil count decreased
|
14.8%
4/27 • Number of events 5 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
18.2%
4/22 • Number of events 10 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Investigations
White blood cell count decreased
|
7.4%
2/27 • Number of events 14 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
18.2%
4/22 • Number of events 9 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.4%
2/27 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
13.6%
3/22 • Number of events 5 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Investigations
Amylase increased
|
7.4%
2/27 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/27 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
18.2%
4/22 • Number of events 4 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Investigations
Platelet count decreased
|
7.4%
2/27 • Number of events 7 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 7 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Investigations
Weight decreased
|
0.00%
0/27 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
18.2%
4/22 • Number of events 4 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/27 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
13.6%
3/22 • Number of events 10 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Investigations
Lipase increased
|
7.4%
2/27 • Number of events 6 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Investigations
Lymphocyte count decreased
|
7.4%
2/27 • Number of events 7 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Investigations
Body temperature increased
|
7.4%
2/27 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/27 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.2%
6/27 • Number of events 9 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
27.3%
6/22 • Number of events 9 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.1%
3/27 • Number of events 4 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.4%
2/27 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.4%
2/27 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.7%
1/27 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.4%
2/27 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
14.8%
4/27 • Number of events 4 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
3/27 • Number of events 4 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.4%
2/27 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
2/27 • Number of events 4 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.8%
4/27 • Number of events 4 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
18.2%
4/22 • Number of events 7 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.4%
2/27 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.4%
2/27 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.4%
2/27 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Infections and infestations
Urinary tract infection
|
18.5%
5/27 • Number of events 5 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Infections and infestations
Lower respiratory tract infection
|
7.4%
2/27 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Infections and infestations
Oral candidiasis
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Infections and infestations
Cystitis
|
7.4%
2/27 • Number of events 4 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.4%
2/27 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Nervous system disorders
Dizziness
|
7.4%
2/27 • Number of events 6 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Nervous system disorders
Headache
|
14.8%
4/27 • Number of events 5 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Nervous system disorders
Lethargy
|
7.4%
2/27 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Psychiatric disorders
Insomnia
|
7.4%
2/27 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
13.6%
3/22 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Psychiatric disorders
Depression
|
3.7%
1/27 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
13.6%
3/22 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Psychiatric disorders
Anxiety
|
7.4%
2/27 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
4.5%
1/22 • Number of events 1 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
18.5%
5/27 • Number of events 5 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
0.00%
0/22 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Renal and urinary disorders
Proteinuria
|
11.1%
3/27 • Number of events 11 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 9 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/27 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/27 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Vascular disorders
Hypertension
|
7.4%
2/27 • Number of events 12 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
13.6%
3/22 • Number of events 4 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
7.4%
2/27 • Number of events 2 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
9.1%
2/22 • Number of events 3 • The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months.
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
|
Additional Information
Lindsay Caygill Clinical Trial Manager
Ferring Ventures Ltd
Phone: +44 (0) 74 213 02230
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place