Trial Outcomes & Findings for VAccination in Early and ADvanced Prostate caNCEr (NCT NCT03815942)
NCT ID: NCT03815942
Last Updated: 2025-06-25
Results Overview
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. Note: All participants had one or more adverse events during the period they were monitored.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
23 participants
Primary outcome timeframe
From baseline to 12 months
Results posted on
2025-06-25
Participant Flow
Participant milestones
| Measure |
Intermediate Risk Prostate Cancer
ChAdOx1.5T4 on week 0 followed by booster injection of MVA.5T4 and nivolumab infusion on week 1. Patients will undergo radical prostatectomy on week 6.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
Advanced Metastatic Prostate Cancer
ChAdOx1.5T4 on week 0 followed by booster injections of MVA.5T4 on week 4, ChAdOx1.5T4 on week 12 and MVA.5T4 on week 16. Nivolumab infusions are to be administered on week 4, 8 and 12.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
23
|
|
Overall Study
COMPLETED
|
0
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
17
|
Reasons for withdrawal
| Measure |
Intermediate Risk Prostate Cancer
ChAdOx1.5T4 on week 0 followed by booster injection of MVA.5T4 and nivolumab infusion on week 1. Patients will undergo radical prostatectomy on week 6.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
Advanced Metastatic Prostate Cancer
ChAdOx1.5T4 on week 0 followed by booster injections of MVA.5T4 on week 4, ChAdOx1.5T4 on week 12 and MVA.5T4 on week 16. Nivolumab infusions are to be administered on week 4, 8 and 12.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
17
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intermediate Risk Prostate Cancer
ChAdOx1.5T4 on week 0 followed by booster injection of MVA.5T4 and nivolumab infusion on week 1. Patients will undergo radical prostatectomy on week 6.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
Advanced Metastatic Prostate Cancer
n=23 Participants
ChAdOx1.5T4 on week 0 followed by booster injections of MVA.5T4 on week 4, ChAdOx1.5T4 on week 12 and MVA.5T4 on week 16. Nivolumab infusions are to be administered on week 4, 8 and 12.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
|
2 Participants
n=23 Participants
|
2 Participants
n=23 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
|
21 Participants
n=23 Participants
|
21 Participants
n=23 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
|
23 Participants
n=23 Participants
|
23 Participants
n=23 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
—
|
23 participants
n=23 Participants
|
23 participants
n=23 Participants
|
|
Serum PSA
|
—
|
23 participants
n=23 Participants
|
23 participants
n=23 Participants
|
PRIMARY outcome
Timeframe: From baseline to 12 monthsPopulation: No participants were recruited in the Intermediate risk prostate cancer group
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. Note: All participants had one or more adverse events during the period they were monitored.
Outcome measures
| Measure |
Intermediate Risk Prostate Cancer
ChAdOx1.5T4 on week 0 followed by booster injection of MVA.5T4 and nivolumab infusion on week 1. Patients will undergo radical prostatectomy on week 6.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
Advanced Metastatic Prostate Cancer
n=23 Participants
ChAdOx1.5T4 on week 0 followed by booster injections of MVA.5T4 on week 4, ChAdOx1.5T4 on week 12 and MVA.5T4 on week 16. Nivolumab infusions are to be administered on week 4, 8 and 12.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
|---|---|---|
|
Safety - Incidence of Treatment-related Adverse Events.
|
—
|
23 Participants
|
PRIMARY outcome
Timeframe: From baseline to 12 monthsPopulation: No participants recruited to the Intermediate risk prostate cancer arm. Change in serum PSA was analysed for this outcome as one the two alternative methods planned. As described in the trial overview, no ctDNA analysis was done due to the trial closing prematurely because of COVID-19 - by the time the pandemic had finished, the facility to perform the ctDNA analysis option was no longer available.
Evaluate the efficacy by assessing the number of participants with 50% or more change in ctDNA or PSA concentration in the blood from baseline to 12 months post treatment. Change in serum PSA was analysed for this outcome as one the two alternative methods planned. As described in the trial overview, no ctDNA analysis was done due to the trial closing prematurely because of COVID-19 - by the time the pandemic had finished, the facility to perform the ctDNA analysis option was no longer available. Because no laboratory analysis was done, there is no data to report.
Outcome measures
| Measure |
Intermediate Risk Prostate Cancer
ChAdOx1.5T4 on week 0 followed by booster injection of MVA.5T4 and nivolumab infusion on week 1. Patients will undergo radical prostatectomy on week 6.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
Advanced Metastatic Prostate Cancer
n=23 Participants
ChAdOx1.5T4 on week 0 followed by booster injections of MVA.5T4 on week 4, ChAdOx1.5T4 on week 12 and MVA.5T4 on week 16. Nivolumab infusions are to be administered on week 4, 8 and 12.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
|---|---|---|
|
Efficacy - Measure Composite Response Rate Defined as One of the Following: 1) Change in Circulating Tumour DNA 2) Change in Serum PSA
|
—
|
5 Participants
|
SECONDARY outcome
Timeframe: From baseline to 12 monthsPopulation: No participants recruited to the Intermediate risk prostate cancer arm
Number of participants with peripheral 5T4-specific T cell responses secondary to treatment
Outcome measures
| Measure |
Intermediate Risk Prostate Cancer
ChAdOx1.5T4 on week 0 followed by booster injection of MVA.5T4 and nivolumab infusion on week 1. Patients will undergo radical prostatectomy on week 6.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
Advanced Metastatic Prostate Cancer
n=23 Participants
ChAdOx1.5T4 on week 0 followed by booster injections of MVA.5T4 on week 4, ChAdOx1.5T4 on week 12 and MVA.5T4 on week 16. Nivolumab infusions are to be administered on week 4, 8 and 12.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
|---|---|---|
|
Evaluate Immune Responses to the Vaccine Antigen in the Periphery
|
—
|
23 Participants
|
SECONDARY outcome
Timeframe: From baseline to radical prostatectomy, an expected average of 6 weeksPopulation: No participants recruited to the Intermediate risk prostate cancer arm
Number of participants with intraprostatic infiltration of CD3+CD8+ T cells secondary to treatment
Outcome measures
| Measure |
Intermediate Risk Prostate Cancer
ChAdOx1.5T4 on week 0 followed by booster injection of MVA.5T4 and nivolumab infusion on week 1. Patients will undergo radical prostatectomy on week 6.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
Advanced Metastatic Prostate Cancer
n=23 Participants
ChAdOx1.5T4 on week 0 followed by booster injections of MVA.5T4 on week 4, ChAdOx1.5T4 on week 12 and MVA.5T4 on week 16. Nivolumab infusions are to be administered on week 4, 8 and 12.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
|---|---|---|
|
Evaluate Immune Cell Subsets in the Prostate Secondary to Treatment (for Surgical Cohort)
|
—
|
23 Participants
|
SECONDARY outcome
Timeframe: 6-12 monthsPopulation: No participants recruited to the Intermediate risk prostate cancer arm
Evaluating the number of participants experiencing progression-free survival at 6 and 12 months post treatment
Outcome measures
| Measure |
Intermediate Risk Prostate Cancer
ChAdOx1.5T4 on week 0 followed by booster injection of MVA.5T4 and nivolumab infusion on week 1. Patients will undergo radical prostatectomy on week 6.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
Advanced Metastatic Prostate Cancer
n=23 Participants
ChAdOx1.5T4 on week 0 followed by booster injections of MVA.5T4 on week 4, ChAdOx1.5T4 on week 12 and MVA.5T4 on week 16. Nivolumab infusions are to be administered on week 4, 8 and 12.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
|---|---|---|
|
Evaluate Progression-free Survival Following Study Treatment (for Advanced Metastatic Cancer Cohort)
|
—
|
23 Participants
|
SECONDARY outcome
Timeframe: 6-12 monthsPopulation: No participants recruited to the Intermediate risk prostate cancer arm
Evaluating the number of participants experiencing overall survival at 6 and 12 months post treatment
Outcome measures
| Measure |
Intermediate Risk Prostate Cancer
ChAdOx1.5T4 on week 0 followed by booster injection of MVA.5T4 and nivolumab infusion on week 1. Patients will undergo radical prostatectomy on week 6.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
Advanced Metastatic Prostate Cancer
n=23 Participants
ChAdOx1.5T4 on week 0 followed by booster injections of MVA.5T4 on week 4, ChAdOx1.5T4 on week 12 and MVA.5T4 on week 16. Nivolumab infusions are to be administered on week 4, 8 and 12.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
|---|---|---|
|
Evaluate Overall Survival Following Study Treatment (for Advanced Metastatic Cancer Cohort)
|
—
|
23 Participants
|
Adverse Events
Intermediate Risk Prostate Cancer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Advanced Metastatic Prostate Cancer
Serious events: 9 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intermediate Risk Prostate Cancer
ChAdOx1.5T4 on week 0 followed by booster injection of MVA.5T4 and nivolumab infusion on week 1. Patients will undergo radical prostatectomy on week 6.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
Advanced Metastatic Prostate Cancer
n=23 participants at risk
ChAdOx1.5T4 on week 0 followed by booster injections of MVA.5T4 on week 4, ChAdOx1.5T4 on week 12 and MVA.5T4 on week 16. Nivolumab infusions are to be administered on week 4, 8 and 12.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
|---|---|---|
|
Blood and lymphatic system disorders
fatigue/haematura/increasing lymphoedema
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Renal and urinary disorders
Possibly urosepsis
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Renal and urinary disorders
Worsening renal failure
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Musculoskeletal and connective tissue disorders
Metastatic spinal cord compression
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
8.7%
2/23 • Number of events 2 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Musculoskeletal and connective tissue disorders
increasing back pain & right arm weakness
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Blood and lymphatic system disorders
pyrexia and rigors
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Musculoskeletal and connective tissue disorders
progressive lower back pain
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Renal and urinary disorders
Kidney injury
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Respiratory, thoracic and mediastinal disorders
Suspected pulmonary clots -> Chest infection (lifelong smoker)
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
Other adverse events
| Measure |
Intermediate Risk Prostate Cancer
ChAdOx1.5T4 on week 0 followed by booster injection of MVA.5T4 and nivolumab infusion on week 1. Patients will undergo radical prostatectomy on week 6.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
Advanced Metastatic Prostate Cancer
n=23 participants at risk
ChAdOx1.5T4 on week 0 followed by booster injections of MVA.5T4 on week 4, ChAdOx1.5T4 on week 12 and MVA.5T4 on week 16. Nivolumab infusions are to be administered on week 4, 8 and 12.
ChAdOx1-MVA 5T4 vaccine: ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units
Nivolumab Infusion \[Opdivo\]: Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
|
|---|---|---|
|
General disorders
Fatigue
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
95.7%
22/23 • Number of events 22 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Fever
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
30.4%
7/23 • Number of events 7 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Headache
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
8.7%
2/23 • Number of events 2 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Myalgia
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
43.5%
10/23 • Number of events 10 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Arthralgia
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
30.4%
7/23 • Number of events 7 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Anorexia
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
39.1%
9/23 • Number of events 9 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Rash
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
43.5%
10/23 • Number of events 10 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Itch General
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
8.7%
2/23 • Number of events 2 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Itch (Local)
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
13.0%
3/23 • Number of events 3 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
21.7%
5/23 • Number of events 5 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
8.7%
2/23 • Number of events 2 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Gastrointestinal disorders
Diarrhoea
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
17.4%
4/23 • Number of events 4 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Abdominal pain
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
30.4%
7/23 • Number of events 7 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Renal and urinary disorders
Urinary
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
43.5%
10/23 • Number of events 10 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Warmth
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
17.4%
4/23 • Number of events 4 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Renal and urinary disorders
acute kidney injury
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Nervous system disorders
Altered sensation right finger/thumb
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
13.0%
3/23 • Number of events 3 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Blood and lymphatic system disorders
Anaemia
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Asthenia
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
8.7%
2/23 • Number of events 3 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Back ache
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
26.1%
6/23 • Number of events 6 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Blood and lymphatic system disorders
Bilateral lower limb oedema
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
13.0%
3/23 • Number of events 3 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Eye disorders
Bilateral Subconjunctival Ulcers
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
8.7%
2/23 • Number of events 2 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Gastrointestinal disorders
Black stools
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Bloatedness
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Respiratory, thoracic and mediastinal disorders
Breathlessness
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
8.7%
2/23 • Number of events 2 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
8.7%
2/23 • Number of events 2 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Respiratory, thoracic and mediastinal disorders
Chest infection
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
17.4%
4/23 • Number of events 4 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Collapse
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
30.4%
7/23 • Number of events 7 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Gastrointestinal disorders
Diarrhoea and vomiting
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
13.0%
3/23 • Number of events 3 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Musculoskeletal and connective tissue disorders
Discomfort (right) sacrum
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
21.7%
5/23 • Number of events 7 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Dizziness
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Dry mouth
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
8.7%
2/23 • Number of events 2 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Investigations
Elevated Amylase
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Fall
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
8.7%
2/23 • Number of events 3 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Renal and urinary disorders
Haematuria
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Hot flushes
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Hepatobiliary disorders
Hyperglycemia
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Blood and lymphatic system disorders
hypotension post vaccine
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
8.7%
2/23 • Number of events 2 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Renal and urinary disorders
Kidney function
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Skin and subcutaneous tissue disorders
left thigh wart
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Musculoskeletal and connective tissue disorders
Leg Ache / weakness
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
26.1%
6/23 • Number of events 8 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Lack of appetite
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Low mood
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Skin and subcutaneous tissue disorders
Lower abdomen skin lesions
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Blood and lymphatic system disorders
lymphocytopenia
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Nausea
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 2 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Musculoskeletal and connective tissue disorders
pain in arm
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
pain injection site L thigh
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
8.7%
2/23 • Number of events 3 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Gastrointestinal disorders
PR Bleeding
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Hepatobiliary disorders
Raised ALT
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Raised temperature
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Skin and subcutaneous tissue disorders
rash right leg and hand
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Musculoskeletal and connective tissue disorders
Rib pain
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Gastrointestinal disorders
Right Iliac pain
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
8.7%
2/23 • Number of events 2 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Nervous system disorders
Sciatica
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Shivery
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Sore mouth
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
13.0%
3/23 • Number of events 3 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Musculoskeletal and connective tissue disorders
Stiff joints
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Skin and subcutaneous tissue disorders
Stye left lower eyelid
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Thirst
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
8.7%
2/23 • Number of events 2 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Blood and lymphatic system disorders
thrombosis in the coeliac axis
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Musculoskeletal and connective tissue disorders
Tooth Ache
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
13.0%
3/23 • Number of events 3 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Vertigo
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
General disorders
Lethargy
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
|
Skin and subcutaneous tissue disorders
Buttock abscess
|
—
0/0 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
4.3%
1/23 • Number of events 1 • For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.
Assessment of serious events was performed according to ICH-GCP guidelines.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place