Trial Outcomes & Findings for Trial Investigating an Immunostimulatory Oncolytic Adenovirus for Cancer (NCT NCT03225989)
NCT ID: NCT03225989
Last Updated: 2024-11-19
Results Overview
The toxicity symptoms were graded according to CTCAE v4.03.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Up to 50 weeks
Results posted on
2024-11-19
Participant Flow
Overall, a total of 47 subjects signed the informed consent, 5 out of 47 subjects were screening failures and 42 subjects were assigned to the study treatment (Group 1, 2 or 3). One subject was assigned to Group 3, but was not exposed to the study treatment.
Participant milestones
| Measure |
Group 1 LOAd703 5x10e10 VP + SOC Tailored to the Indication
LOAd703 (5x10e10 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 2 LOAd703 1x10e11 VP + SOC Tailored to the Indication
LOAd703 (1x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 3 LOAd703 5x10e11 VP + SOC Tailored to the Indication
LOAd703 (5x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
|---|---|---|---|
|
Group 1: LOAd703 Dose Level 5x10e10VP
STARTED
|
3
|
0
|
0
|
|
Group 1: LOAd703 Dose Level 5x10e10VP
COMPLETED
|
1
|
0
|
0
|
|
Group 1: LOAd703 Dose Level 5x10e10VP
NOT COMPLETED
|
2
|
0
|
0
|
|
Group 2: LOAd703 Dose Level 1x10e11 VP
STARTED
|
0
|
12
|
0
|
|
Group 2: LOAd703 Dose Level 1x10e11 VP
COMPLETED
|
0
|
2
|
0
|
|
Group 2: LOAd703 Dose Level 1x10e11 VP
NOT COMPLETED
|
0
|
10
|
0
|
|
Group 3: LOAd703 Dose Level 5x10e11VP
STARTED
|
0
|
0
|
27
|
|
Group 3: LOAd703 Dose Level 5x10e11VP
COMPLETED
|
0
|
0
|
1
|
|
Group 3: LOAd703 Dose Level 5x10e11VP
NOT COMPLETED
|
0
|
0
|
26
|
Reasons for withdrawal
| Measure |
Group 1 LOAd703 5x10e10 VP + SOC Tailored to the Indication
LOAd703 (5x10e10 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 2 LOAd703 1x10e11 VP + SOC Tailored to the Indication
LOAd703 (1x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 3 LOAd703 5x10e11 VP + SOC Tailored to the Indication
LOAd703 (5x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
|---|---|---|---|
|
Group 1: LOAd703 Dose Level 5x10e10VP
Progressive Disease
|
2
|
0
|
0
|
|
Group 2: LOAd703 Dose Level 1x10e11 VP
Adverse Event
|
0
|
1
|
0
|
|
Group 2: LOAd703 Dose Level 1x10e11 VP
Death
|
0
|
1
|
0
|
|
Group 2: LOAd703 Dose Level 1x10e11 VP
Progressive Disease
|
0
|
7
|
0
|
|
Group 2: LOAd703 Dose Level 1x10e11 VP
Other Reason
|
0
|
1
|
0
|
|
Group 3: LOAd703 Dose Level 5x10e11VP
Withdrawal by Subject
|
0
|
0
|
1
|
|
Group 3: LOAd703 Dose Level 5x10e11VP
Adverse Event
|
0
|
0
|
2
|
|
Group 3: LOAd703 Dose Level 5x10e11VP
Death
|
0
|
0
|
4
|
|
Group 3: LOAd703 Dose Level 5x10e11VP
Progressive Disease
|
0
|
0
|
16
|
|
Group 3: LOAd703 Dose Level 5x10e11VP
Physician Decision
|
0
|
0
|
1
|
|
Group 3: LOAd703 Dose Level 5x10e11VP
Not Exposed to LOAd703
|
0
|
0
|
1
|
|
Group 3: LOAd703 Dose Level 5x10e11VP
Other Reason
|
0
|
0
|
1
|
Baseline Characteristics
Trial Investigating an Immunostimulatory Oncolytic Adenovirus for Cancer
Baseline characteristics by cohort
| Measure |
Group 1 LOAd703 5x10e10 VP + SOC Tailored to the Indication
n=3 Participants
LOAd703 (5x10e10 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 2 LOAd703 1x10e11 VP + SOC Tailored to the Indication
n=12 Participants
LOAd703 (1x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 3 LOAd703 5x10e11 VP + SOC Tailored to the Indication
n=27 Participants
LOAd703 (5x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
63.1 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Sweden
|
3 participants
n=5 Participants
|
12 participants
n=7 Participants
|
27 participants
n=5 Participants
|
42 participants
n=4 Participants
|
|
ECOG score
ECOG score 0
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
21 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
ECOG score
ECOG score 1
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
ECOG score
ECOG score 2
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Cancer Diagnosis
Pancreatic cancer
|
1 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Cancer Diagnosis
Colorectal carcinoma
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Cancer Diagnosis
Ovarian cancer
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Cancer Diagnosis
Biliary cancer
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Current oncological disease
Locally advanced
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Current oncological disease
Metastatic
|
3 participants
n=5 Participants
|
8 participants
n=7 Participants
|
23 participants
n=5 Participants
|
34 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 50 weeksPopulation: Overall, a total of 42 subjects were assigned to the study treatment, 1 out of 42 did not receive the study treatment and it was not included in the safety evaluation. The subject who did not receive the study treatment was assigned to group 3.
The toxicity symptoms were graded according to CTCAE v4.03.
Outcome measures
| Measure |
Group 1 LOAd703 5x10e10 VP + SOC Tailored to the Indication
n=3 Participants
LOAd703 (5x10e10 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 2 LOAd703 1x10e11 VP + SOC Tailored to the Indication
n=12 Participants
LOAd703 (1x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 3 LOAd703 5x10e11 VP + SOC Tailored to the Indication
n=26 Participants
LOAd703 (5x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Colorectal Cancer
Response on tumor size by cancer diagnosis for colorectal cancer.
|
Biliary Cancer
Response on tumor size by cancer diagnosis for biliary cancer.
|
Pancreatic Cancer
Response on tumor size by cancer diagnosis for pancreatic cancer.
|
Ovarian Cancer
Response on tumor size by cancer diagnosis for ovarian cancer.
|
|---|---|---|---|---|---|---|---|
|
Safety: Toxicity Symptoms Graded According to CTCAE v4.03.
AE related to LOAd703 grade 5
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
—
|
—
|
—
|
—
|
|
Safety: Toxicity Symptoms Graded According to CTCAE v4.03.
AE unrelated to LOAd703
|
32 Number of Events
|
106 Number of Events
|
242 Number of Events
|
—
|
—
|
—
|
—
|
|
Safety: Toxicity Symptoms Graded According to CTCAE v4.03.
All adverse events (AE)
|
61 Number of Events
|
139 Number of Events
|
411 Number of Events
|
—
|
—
|
—
|
—
|
|
Safety: Toxicity Symptoms Graded According to CTCAE v4.03.
All serious adverse events (SAEs)
|
7 Number of Events
|
31 Number of Events
|
63 Number of Events
|
—
|
—
|
—
|
—
|
|
Safety: Toxicity Symptoms Graded According to CTCAE v4.03.
Serious adverse reactions (SARs) related to LOAd703
|
3 Number of Events
|
4 Number of Events
|
21 Number of Events
|
—
|
—
|
—
|
—
|
|
Safety: Toxicity Symptoms Graded According to CTCAE v4.03.
AE leading to withdrawal from the study
|
0 Number of Events
|
1 Number of Events
|
2 Number of Events
|
—
|
—
|
—
|
—
|
|
Safety: Toxicity Symptoms Graded According to CTCAE v4.03.
AE leading to LOAd703 discontinuation
|
0 Number of Events
|
2 Number of Events
|
6 Number of Events
|
—
|
—
|
—
|
—
|
|
Safety: Toxicity Symptoms Graded According to CTCAE v4.03.
AE leading to death
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
—
|
—
|
—
|
—
|
|
Safety: Toxicity Symptoms Graded According to CTCAE v4.03.
AE related to LOAd703
|
29 Number of Events
|
33 Number of Events
|
169 Number of Events
|
—
|
—
|
—
|
—
|
|
Safety: Toxicity Symptoms Graded According to CTCAE v4.03.
AE related to LOAd703 grade 1
|
15 Number of Events
|
29 Number of Events
|
111 Number of Events
|
—
|
—
|
—
|
—
|
|
Safety: Toxicity Symptoms Graded According to CTCAE v4.03.
AE related to LOAd703 grade 2
|
14 Number of Events
|
3 Number of Events
|
52 Number of Events
|
—
|
—
|
—
|
—
|
|
Safety: Toxicity Symptoms Graded According to CTCAE v4.03.
AE related to LOAd703 grade 3
|
0 Number of Events
|
0 Number of Events
|
6 Number of Events
|
—
|
—
|
—
|
—
|
|
Safety: Toxicity Symptoms Graded According to CTCAE v4.03.
AE related to LOAd703 grade 4
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 50 weeksFold change between baseline and evaluation visit for anti-adenovirus antibodies (LOAd703). The baseline is the last available measurement taken before the first LOAd703 treatment. Evaluation is a measurement taken from subjects receiving at least 3 LOAd703 treatments.
Outcome measures
| Measure |
Group 1 LOAd703 5x10e10 VP + SOC Tailored to the Indication
n=3 Participants
LOAd703 (5x10e10 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 2 LOAd703 1x10e11 VP + SOC Tailored to the Indication
n=12 Participants
LOAd703 (1x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 3 LOAd703 5x10e11 VP + SOC Tailored to the Indication
n=24 Participants
LOAd703 (5x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Colorectal Cancer
Response on tumor size by cancer diagnosis for colorectal cancer.
|
Biliary Cancer
Response on tumor size by cancer diagnosis for biliary cancer.
|
Pancreatic Cancer
Response on tumor size by cancer diagnosis for pancreatic cancer.
|
Ovarian Cancer
Response on tumor size by cancer diagnosis for ovarian cancer.
|
|---|---|---|---|---|---|---|---|
|
Immune Reactions to LOAd703 Virus as Assessed by Anti-adenovirus Ig ELISA
|
41.63 fold change
Standard Deviation 8.39
|
15.81 fold change
Standard Deviation 10.33
|
31.77 fold change
Standard Deviation 24.31
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 50 weeksPopulation: Response on tumor size was evaluated in participants who have received at least 3 doses of LOAd703 and performed computed tomography (CT) evaluation at baseline and at week 9 (Visit 5). Group 1 (5x10e10 VP): all the 3 participants met the criteria to be included in this analysis; Group 2 (1x10e11 VP): from a total of 12 participants, 10 met the criteria to be included in this analysis; Group 3 (5x10e11 VP): from a total of 27 participants, 22 met the criteria to be included in this analysis.
Local and distant anti-tumoral size changes assessed by appropriate imaging accordingly to RECIST 1.1. Complete Response (CR), complete macroscopic disappearance of all tumors; Partial Response (PR), a reduction of at least 30% in the sum of all tumor diameters from baseline; one/more lesions fulfilling the criteria for PR and other/others for progressive disease (PD); Stable disease (SD), Neither PR nor PD; Progressive disease (PD), at least 20% increase in the sum of all tumor diameters from the smallest tumor size and/or the appearance of new tumor lesion/s; Overall response rate (ORR) = CR + PR; Clinical benefit rate (CBR) = CR + PR + SD.
Outcome measures
| Measure |
Group 1 LOAd703 5x10e10 VP + SOC Tailored to the Indication
n=3 Participants
LOAd703 (5x10e10 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 2 LOAd703 1x10e11 VP + SOC Tailored to the Indication
n=10 Participants
LOAd703 (1x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 3 LOAd703 5x10e11 VP + SOC Tailored to the Indication
n=22 Participants
LOAd703 (5x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Colorectal Cancer
n=5 Participants
Response on tumor size by cancer diagnosis for colorectal cancer.
|
Biliary Cancer
n=3 Participants
Response on tumor size by cancer diagnosis for biliary cancer.
|
Pancreatic Cancer
n=24 Participants
Response on tumor size by cancer diagnosis for pancreatic cancer.
|
Ovarian Cancer
n=3 Participants
Response on tumor size by cancer diagnosis for ovarian cancer.
|
|---|---|---|---|---|---|---|---|
|
Response on Tumor Size by Dose and Cancer Diagnosis
Complete response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response on Tumor Size by Dose and Cancer Diagnosis
Partial response (PR)
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
|
Response on Tumor Size by Dose and Cancer Diagnosis
Stable disease (SD)
|
1 Participants
|
4 Participants
|
11 Participants
|
2 Participants
|
1 Participants
|
11 Participants
|
2 Participants
|
|
Response on Tumor Size by Dose and Cancer Diagnosis
Progressive disease (PD)
|
2 Participants
|
3 Participants
|
8 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
1 Participants
|
|
Response on Tumor Size by Dose and Cancer Diagnosis
Overall response rate (ORR)
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
|
Response on Tumor Size by Dose and Cancer Diagnosis
Clinical benefit rate (CBR)
|
1 Participants
|
7 Participants
|
14 Participants
|
2 Participants
|
1 Participants
|
17 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From registration date to date of death, assessed up to 40 monthsPopulation: OS was evaluated in participants who have received at least 3 doses of LOAd703 and performed computed tomography (CT) evaluation at baseline and at week 9 (Visit 5). Group 1 (5x10e10 VP): all the 3 participants met the criteria to be included in this analysis; Group 2 (1x10e11 VP): from a total of 12 participants, 10 met the criteria to be included in this analysis; Group 3 (5x10e11 VP): from a total of 27 participants, 22 met the criteria to be included in this analysis.
Months of overall survival (OS) from registration by dose and cancer diagnosis
Outcome measures
| Measure |
Group 1 LOAd703 5x10e10 VP + SOC Tailored to the Indication
n=3 Participants
LOAd703 (5x10e10 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 2 LOAd703 1x10e11 VP + SOC Tailored to the Indication
n=10 Participants
LOAd703 (1x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 3 LOAd703 5x10e11 VP + SOC Tailored to the Indication
n=22 Participants
LOAd703 (5x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Colorectal Cancer
n=5 Participants
Response on tumor size by cancer diagnosis for colorectal cancer.
|
Biliary Cancer
n=3 Participants
Response on tumor size by cancer diagnosis for biliary cancer.
|
Pancreatic Cancer
n=24 Participants
Response on tumor size by cancer diagnosis for pancreatic cancer.
|
Ovarian Cancer
n=3 Participants
Response on tumor size by cancer diagnosis for ovarian cancer.
|
|---|---|---|---|---|---|---|---|
|
Overall Survival
|
4.40 Months
Interval 3.02 to 12.85
|
8.44 Months
Interval 2.66 to 40.54
|
7.38 Months
Interval 5.39 to 10.71
|
5.36 Months
Interval 3.02 to 8.44
|
6.64 Months
Interval 5.26 to 7.46
|
7.29 Months
Interval 5.39 to 12.85
|
40.54 Months
Interval 9.69 to 40.54
|
SECONDARY outcome
Timeframe: From registration date to date of progression, assessed up to 40 monthsPopulation: Time to progression was evaluated in participants who have received at least 3 doses of LOAd703 and performed computed tomography (CT) evaluation at baseline and at week 9 (Visit 5). Group 1 (5x10e10 VP): all the 3 participants met the criteria to be included in this analysis; Group 2 (1x10e11 VP): from a total of 12 participants, 10 met the criteria to be included in this analysis; Group 3 (5x10e11 VP): from a total of 27 participants, 22 met the criteria to be included in this analysis.
Time to progression from registration by dose and cancer diagnosis
Outcome measures
| Measure |
Group 1 LOAd703 5x10e10 VP + SOC Tailored to the Indication
n=3 Participants
LOAd703 (5x10e10 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 2 LOAd703 1x10e11 VP + SOC Tailored to the Indication
n=10 Participants
LOAd703 (1x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 3 LOAd703 5x10e11 VP + SOC Tailored to the Indication
n=22 Participants
LOAd703 (5x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Colorectal Cancer
n=5 Participants
Response on tumor size by cancer diagnosis for colorectal cancer.
|
Biliary Cancer
n=3 Participants
Response on tumor size by cancer diagnosis for biliary cancer.
|
Pancreatic Cancer
n=24 Participants
Response on tumor size by cancer diagnosis for pancreatic cancer.
|
Ovarian Cancer
n=3 Participants
Response on tumor size by cancer diagnosis for ovarian cancer.
|
|---|---|---|---|---|---|---|---|
|
Time to Progression
|
2.40 Months
Interval 1.74 to 3.68
|
3.79 Months
Interval 1.81 to 5.49
|
3.88 Months
Interval 1.87 to 5.72
|
2.40 Months
Interval 1.74 to 3.84
|
1.81 Months
Interval 1.58 to 4.76
|
3.75 Months
Interval 2.27 to 5.72
|
3.88 Months
Interval 1.87 to 20.07
|
SECONDARY outcome
Timeframe: From registration date to date of progression, or date of death, which ever came first, assessed up to 40 monthsPopulation: PFS was evaluated in participants who have received at least 3 doses of LOAd703 and performed computed tomography (CT) evaluation at baseline and at week 9 (Visit 5). Group 1 (5x10e10 VP): all the 3 participants met the criteria to be included in this analysis; Group 2 (1x10e11 VP): from a total of 12 participants, 10 met the criteria to be included in this analysis; Group 3 (5x10e11 VP): from a total of 27 participants, 22 met the criteria to be included in this analysis.
Months of progression free survival (PFS) from registration by dose and cancer diagnosis
Outcome measures
| Measure |
Group 1 LOAd703 5x10e10 VP + SOC Tailored to the Indication
n=3 Participants
LOAd703 (5x10e10 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 2 LOAd703 1x10e11 VP + SOC Tailored to the Indication
n=10 Participants
LOAd703 (1x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 3 LOAd703 5x10e11 VP + SOC Tailored to the Indication
n=22 Participants
LOAd703 (5x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Colorectal Cancer
n=5 Participants
Response on tumor size by cancer diagnosis for colorectal cancer.
|
Biliary Cancer
n=3 Participants
Response on tumor size by cancer diagnosis for biliary cancer.
|
Pancreatic Cancer
n=24 Participants
Response on tumor size by cancer diagnosis for pancreatic cancer.
|
Ovarian Cancer
n=3 Participants
Response on tumor size by cancer diagnosis for ovarian cancer.
|
|---|---|---|---|---|---|---|---|
|
Progression Free Survival
|
2.40 Months
Interval 1.74 to 3.68
|
3.79 Months
Interval 1.81 to 5.49
|
4.32 Months
Interval 1.87 to 5.72
|
2.40 Months
Interval 1.74 to 5.36
|
1.81 Months
Interval 1.58 to 4.76
|
4.62 Months
Interval 2.27 to 5.72
|
3.88 Months
Interval 1.87 to 20.07
|
SECONDARY outcome
Timeframe: Up to 50 weeksPercentage of participants with upregulated immune marker in blood at evaluation as compared to baseline. The baseline is the last available measurement taken before the first LOAd703 treatment. Evaluation is a measurement taken from subjects receiving at least 3 LOAd703 treatments.
Outcome measures
| Measure |
Group 1 LOAd703 5x10e10 VP + SOC Tailored to the Indication
n=3 Participants
LOAd703 (5x10e10 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 2 LOAd703 1x10e11 VP + SOC Tailored to the Indication
n=11 Participants
LOAd703 (1x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 3 LOAd703 5x10e11 VP + SOC Tailored to the Indication
n=25 Participants
LOAd703 (5x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Colorectal Cancer
Response on tumor size by cancer diagnosis for colorectal cancer.
|
Biliary Cancer
Response on tumor size by cancer diagnosis for biliary cancer.
|
Pancreatic Cancer
Response on tumor size by cancer diagnosis for pancreatic cancer.
|
Ovarian Cancer
Response on tumor size by cancer diagnosis for ovarian cancer.
|
|---|---|---|---|---|---|---|---|
|
Systemic Immune Activation
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 50 weeksFold change between baseline and evaluation visit for CD8+ CD3+ T cells activation evaluated by flow cytometry. The baseline is the last available measurement taken before the first LOAd703 treatment. Evaluation is a measurement taken from subjects receiving at least 3 LOAd703 treatments.
Outcome measures
| Measure |
Group 1 LOAd703 5x10e10 VP + SOC Tailored to the Indication
n=3 Participants
LOAd703 (5x10e10 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 2 LOAd703 1x10e11 VP + SOC Tailored to the Indication
n=11 Participants
LOAd703 (1x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 3 LOAd703 5x10e11 VP + SOC Tailored to the Indication
n=25 Participants
LOAd703 (5x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Colorectal Cancer
Response on tumor size by cancer diagnosis for colorectal cancer.
|
Biliary Cancer
Response on tumor size by cancer diagnosis for biliary cancer.
|
Pancreatic Cancer
Response on tumor size by cancer diagnosis for pancreatic cancer.
|
Ovarian Cancer
Response on tumor size by cancer diagnosis for ovarian cancer.
|
|---|---|---|---|---|---|---|---|
|
Immune Cell Activation
|
1.01 fold change
Standard Deviation 0.39
|
1.19 fold change
Standard Deviation 0.32
|
1.17 fold change
Standard Deviation 0.48
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 50 weeksPercentage of PK samples analyzed that were positive for viral DNA/ml in serum.
Outcome measures
| Measure |
Group 1 LOAd703 5x10e10 VP + SOC Tailored to the Indication
n=18 Blood samples
LOAd703 (5x10e10 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 2 LOAd703 1x10e11 VP + SOC Tailored to the Indication
n=93 Blood samples
LOAd703 (1x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 3 LOAd703 5x10e11 VP + SOC Tailored to the Indication
n=186 Blood samples
LOAd703 (5x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Colorectal Cancer
Response on tumor size by cancer diagnosis for colorectal cancer.
|
Biliary Cancer
Response on tumor size by cancer diagnosis for biliary cancer.
|
Pancreatic Cancer
Response on tumor size by cancer diagnosis for pancreatic cancer.
|
Ovarian Cancer
Response on tumor size by cancer diagnosis for ovarian cancer.
|
|---|---|---|---|---|---|---|---|
|
Presence of LOAd703 Virus in Blood
|
22.22 Percentage of positive samples
|
16.13 Percentage of positive samples
|
35.48 Percentage of positive samples
|
—
|
—
|
—
|
—
|
Adverse Events
Group 1 LOAd703 5x10e10 VP + SOC Tailored to the Indication
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Group 2 LOAd703 1x10e11 VP + SOC Tailored to the Indication
Serious events: 12 serious events
Other events: 11 other events
Deaths: 10 deaths
Group 3 LOAd703 5x10e11 VP + SOC Tailored to the Indication
Serious events: 20 serious events
Other events: 26 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Group 1 LOAd703 5x10e10 VP + SOC Tailored to the Indication
n=3 participants at risk
LOAd703 (5x10e10 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 2 LOAd703 1x10e11 VP + SOC Tailored to the Indication
n=12 participants at risk
LOAd703 (1x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 3 LOAd703 5x10e11 VP + SOC Tailored to the Indication
n=26 participants at risk
LOAd703 (5x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
|---|---|---|---|
|
General disorders
Pyrexia
|
33.3%
1/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
42.3%
11/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
General physical health deterioration
|
33.3%
1/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
11.5%
3/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
16.7%
2/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
15.4%
4/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
16.7%
2/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
15.4%
4/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Product Issues
Device dislocation
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Renal and urinary disorders
Glomerulonephritis membranoproliferative
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
Other adverse events
| Measure |
Group 1 LOAd703 5x10e10 VP + SOC Tailored to the Indication
n=3 participants at risk
LOAd703 (5x10e10 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 2 LOAd703 1x10e11 VP + SOC Tailored to the Indication
n=12 participants at risk
LOAd703 (1x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
Group 3 LOAd703 5x10e11 VP + SOC Tailored to the Indication
n=26 participants at risk
LOAd703 (5x10e11 VP) oncolytic adenovirus administered add-on to standard of care chemotherapy or gemcitabine immune-conditioning if standard of care is no longer an option (e.g. after last line)
LOAd703: Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
33.3%
4/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
30.8%
8/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
25.0%
3/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Cardiac disorders
Palpitations
|
33.3%
1/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
16.7%
2/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
15.4%
4/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
41.7%
5/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
61.5%
16/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Proctalgia
|
33.3%
1/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
16.7%
2/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
38.5%
10/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
16.7%
2/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
19.2%
5/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
16.7%
2/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
23.1%
6/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Gingival blister
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Chills
|
100.0%
3/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
25.0%
3/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
42.3%
11/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
58.3%
7/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
61.5%
16/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
General physical health deterioration
|
33.3%
1/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Malaise
|
33.3%
1/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Oedema peripheral
|
66.7%
2/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
41.7%
5/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
23.1%
6/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Pyrexia
|
100.0%
3/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
66.7%
8/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
92.3%
24/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Discomfort
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Gastroenteritis
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Injection site oedema
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Localised oedema
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Face oedema
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Feeling cold
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Injection site inflammation
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Injection site pain
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
General disorders
Swelling
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
16.7%
2/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Infections and infestations
Groin infection
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Injury, poisoning and procedural complications
Peripancreatic fluid collection
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
15.4%
4/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
16.7%
2/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
23.1%
6/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Cardiac murmur
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Heart rate irregular
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
19.2%
5/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
11.5%
3/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
19.2%
5/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
11.5%
3/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Investigations
Weight increased
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
11.5%
3/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
16.7%
2/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
2/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
15.4%
4/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
11.5%
3/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour thrombosis
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
16.7%
2/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
23.1%
6/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
11.5%
3/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
25.0%
3/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
11.5%
3/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Renal and urinary disorders
Glomerulonephritis membranoproliferative
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
66.7%
2/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
16.7%
2/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
33.3%
1/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
8.3%
1/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
16.7%
2/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
15.4%
4/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
16.7%
2/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
11.5%
3/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
7.7%
2/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
0.00%
0/12 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
3.8%
1/26 • Adverse events were collected from the first LOAd703/chemotherapy treatment up to 50 weeks (final follow-up). All-Cause Mortality was assessed from registration date to date of death, assessed up to 40 months.
The number of participants with adverse events and not the number of events are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place