Trial Outcomes & Findings for Chemoradiation With Enadenotucirev as a Radiosensitiser in Locally Advanced Rectal Cancer (NCT NCT03916510)
NCT ID: NCT03916510
Last Updated: 2025-02-06
Results Overview
Dose escalation for this trial was informed by a Time To Event Continual Reassessment Method (TiTE CRM). This statistical model was also able to determine the optimal dose schedule of enadenotucirev that can be administered with chemoradiation (highest treatment schedule resulting in less than 30% dose limiting toxicity rate). The definition of a DLT for this trial can be found in the study description section of this record.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
From Day 1 of treatment to Week 13 (13 weeks +/- 3 days)
Results posted on
2025-02-06
Participant Flow
The first patient was registered on 29Jul2019 and the final study visit for the final patient was on 28Oct2022.
Participant milestones
| Measure |
Dosing Group 1
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 2
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*). 3 x maintenance doses post-chemoradiation (low-low-low\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 3
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low)\*. 3 x maintenance doses post-chemoradiation (low-high-high)\*.
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 4
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-high-high\*). 2 x concurrent doses on week 1, days 1 and 5 of chemoradiation (high-high\*). 3 x maintenance doses post-chemoradiation (low-high-high\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
6
|
0
|
|
Overall Study
COMPLETED
|
2
|
4
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dosing Group 1
n=2 Participants
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 2
n=4 Participants
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*). 3 x maintenance doses post-chemoradiation (low-low-low\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 3
n=6 Participants
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*). 3 x maintenance doses post-chemoradiation (low-high-high\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 4
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-high-high\*). 2 x concurrent doses on week 1, days 1 and 5 of chemoradiation (high-high\*). 3 x maintenance doses post-chemoradiation (low-high-high\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.0 Years
n=2 Participants
|
65.5 Years
n=4 Participants
|
63.5 Years
n=6 Participants
|
—
|
61.0 Years
n=12 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
—
|
3 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=6 Participants
|
—
|
9 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
ECOG Performance Status
ECOG performance status = 0
|
2 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=6 Participants
|
—
|
11 Participants
n=12 Participants
|
|
ECOG Performance Status
ECOG performance status = 1
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
—
|
1 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: From Day 1 of treatment to Week 13 (13 weeks +/- 3 days)Population: Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group.
Dose escalation for this trial was informed by a Time To Event Continual Reassessment Method (TiTE CRM). This statistical model was also able to determine the optimal dose schedule of enadenotucirev that can be administered with chemoradiation (highest treatment schedule resulting in less than 30% dose limiting toxicity rate). The definition of a DLT for this trial can be found in the study description section of this record.
Outcome measures
| Measure |
Dosing Group 1
n=2 Participants
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 2
n=4 Participants
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*). 3 x maintenance doses post-chemoradiation (low-low-low\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 3
n=6 Participants
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*). 3 x maintenance doses post-chemoradiation (low-high-high\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 4
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-high-high\*). 2 x concurrent doses on week 1, days 1 and 5 of chemoradiation (high-high\*). 3 x maintenance doses post-chemoradiation (low-high-high\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
|---|---|---|---|---|
|
Number of Participants Who Had a Dose Limiting Toxicity (DLT) Following Treatment With Enadenotucirev and Chemoradiotherapy (Capecitabine and Radiation) at 1 of 4 Different Dosing Schedules.
|
0 participants
|
0 participants
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: 13 weeks after starting treatment (+/- 3 days)Population: Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group.
To inform the optimal dose and frequency of enadenotucirev that can be administered with chemoradiation. The MRI tumour regression grade uses the following scale and for the purposes of the trial analysis and dose escalation, scores of 1 or 2 were classified as responders and scores of 3, 4 or 5 were classified as non-responders: 1. \- No/minimal fibrosis visible (tiny linear scar) and no tumour signal (best outcome) 2. \- Dense fibrotic scar (low signal intensity) but no macroscopic tumour signal (indicates no or microscopic tumour) 3. \- Fibrosis predominates but obvious measurable areas of tumour signal visible 4. \- Tumour signal predominates with little/minimal fibrosis 5. \- Tumour signal only: no fibrosis, includes progression of tumour (worst outcome)
Outcome measures
| Measure |
Dosing Group 1
n=2 Participants
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 2
n=4 Participants
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*). 3 x maintenance doses post-chemoradiation (low-low-low\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 3
n=6 Participants
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*). 3 x maintenance doses post-chemoradiation (low-high-high\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 4
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-high-high\*). 2 x concurrent doses on week 1, days 1 and 5 of chemoradiation (high-high\*). 3 x maintenance doses post-chemoradiation (low-high-high\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
|---|---|---|---|---|
|
Magnetic Resonance Imaging (MRI) Tumour Regression Grade on a Scale of 1-5 for Patients Treated With Enadenotucirev Delivered in Conjunction With Chemoradiotherapy (Capecitabine and Radiation) at 1 of 4 Different Dosing Schedules.
2 - Dense fibrotic scar but no macroscopic tumour signal (indicates no or microscopic tumour)
|
0 participants
|
2 participants
|
2 participants
|
—
|
|
Magnetic Resonance Imaging (MRI) Tumour Regression Grade on a Scale of 1-5 for Patients Treated With Enadenotucirev Delivered in Conjunction With Chemoradiotherapy (Capecitabine and Radiation) at 1 of 4 Different Dosing Schedules.
5 - Tumour signal only: no fibrosis, includes progression of tumour (worst outcome)
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Magnetic Resonance Imaging (MRI) Tumour Regression Grade on a Scale of 1-5 for Patients Treated With Enadenotucirev Delivered in Conjunction With Chemoradiotherapy (Capecitabine and Radiation) at 1 of 4 Different Dosing Schedules.
1 - No/minimal fibrosis visible (tiny linear scar) and no tumour signal (best outcome)
|
0 participants
|
0 participants
|
1 participants
|
—
|
|
Magnetic Resonance Imaging (MRI) Tumour Regression Grade on a Scale of 1-5 for Patients Treated With Enadenotucirev Delivered in Conjunction With Chemoradiotherapy (Capecitabine and Radiation) at 1 of 4 Different Dosing Schedules.
3 - Fibrosis predominates but obvious measurable areas of tumour signal visible
|
0 participants
|
1 participants
|
3 participants
|
—
|
|
Magnetic Resonance Imaging (MRI) Tumour Regression Grade on a Scale of 1-5 for Patients Treated With Enadenotucirev Delivered in Conjunction With Chemoradiotherapy (Capecitabine and Radiation) at 1 of 4 Different Dosing Schedules.
4 - Tumour signal predominates with little/minimal fibrosis
|
2 participants
|
1 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: From start of treatment to end of treatment (9 weeks)Population: Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group.
Ability to deliver enadenotucirev concurrently with chemoradiation, based on treatment tolerance for the combination of enadenotucirev, capecitabine and radiation.
Outcome measures
| Measure |
Dosing Group 1
n=2 Participants
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 2
n=4 Participants
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*). 3 x maintenance doses post-chemoradiation (low-low-low\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 3
n=6 Participants
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*). 3 x maintenance doses post-chemoradiation (low-high-high\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 4
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-high-high\*). 2 x concurrent doses on week 1, days 1 and 5 of chemoradiation (high-high\*). 3 x maintenance doses post-chemoradiation (low-high-high\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
|---|---|---|---|---|
|
Number of Patients Completing at Least 80% of the Intended Capecitabine Dose and at Least 20 Fractions of Radiotherapy.
Received > 80% of intended capecitabine dose and at least 20 fractions of radiotherapy
|
2 Participants
|
4 Participants
|
5 Participants
|
—
|
|
Number of Patients Completing at Least 80% of the Intended Capecitabine Dose and at Least 20 Fractions of Radiotherapy.
Did not receive > 80% of intended capecitabine dose and at least 20 fractions of radiotherapy
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: At 4-6 weeks post surgery (minimum 18 weeks after start of treatment)Population: Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group. In addition, there were 2 participants in dosing group 2 and 2 participants in dosing group 3 who did not have surgery, and therefore were not included in this analysis.
To measure local response rate to combined therapy following treatment with enadenotucirev, capecitabine and radiotherapy. Pathological complete response (pCR) was only observable in patients undergoing surgery. The final resected tumour was assessed by an experienced lower gastrointestinal pathologist and staged according to the Royal College of Pathologists recommended standard datasets as per standard of care. Pathological complete response (pCR) is staged as ypT0N0 - a complete regression of the primary tumour (ypT0), with concurrently no (residual) tumoral invasion of the lymph nodes (ypN0).This notation is part of the TNM staging system used in oncology, where "T" stands for the size and extent of the main tumour, and "N" describes the presence of cancer in nearby lymph nodes.
Outcome measures
| Measure |
Dosing Group 1
n=2 Participants
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 2
n=2 Participants
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*). 3 x maintenance doses post-chemoradiation (low-low-low\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 3
n=4 Participants
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*). 3 x maintenance doses post-chemoradiation (low-high-high\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 4
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-high-high\*). 2 x concurrent doses on week 1, days 1 and 5 of chemoradiation (high-high\*). 3 x maintenance doses post-chemoradiation (low-high-high\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
|---|---|---|---|---|
|
Number of Participants With Pathological Complete Response (pCR) of Tumour Following Resection (Staged According to Royal College of Pathologists Guidelines).
Pathological complete response = no
|
2 Participants
|
2 Participants
|
3 Participants
|
—
|
|
Number of Participants With Pathological Complete Response (pCR) of Tumour Following Resection (Staged According to Royal College of Pathologists Guidelines).
Pathological complete response = yes
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: At 4-6 weeks post surgery (minimum 18 weeks after start of treatment)Population: Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group. In addition, there were 2 participants in dosing group 2 and 2 participants in dosing group 3 who did not have surgery, and therefore were not included in this analysis.
To measure local response rate to combined therapy following treatment with enadenotucirev, capecitabine and radiotherapy. The Neoadjuvant Rectal (NAR) score ranges from 0-100, where a higher score equates to a worse prognosis. The NAR score outperforms pathological complete response (pCR) at predicting disease free survival (DFS) and overall survival (OS) in clinical trials using neoadjuvant therapy for rectal cancer. It similarly performs well at predicting DFS and OS in trials using pre-op chemo and chemoradiotherapy. Ref: George TJ, Allegra CJ, Yothers G. Neoadjuvant Rectal (NAR) Score: a New Surrogate Endpoint in Rectal Cancer Clinical Trials. Curr Colorectal Cancer Rep. 2015;11(5):275-80. NAR = \[5pN - 3(cT - pT) + 12\]\^2 / 9.61 Where: cT is an element of the set {1, 2, 3, 4}, pT is in {0, 1, 2, 3, 4}, pN is in {0, 1, 2}. cT clinical tumour stage, pT pathologic tumour stage, pN pathologic nodal stage
Outcome measures
| Measure |
Dosing Group 1
n=2 Participants
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 2
n=2 Participants
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*). 3 x maintenance doses post-chemoradiation (low-low-low\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 3
n=4 Participants
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*). 3 x maintenance doses post-chemoradiation (low-high-high\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 4
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-high-high\*). 2 x concurrent doses on week 1, days 1 and 5 of chemoradiation (high-high\*). 3 x maintenance doses post-chemoradiation (low-high-high\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
|---|---|---|---|---|
|
Neoadjuvant Rectal (NAR) Score on a Scale of 0-100 Following Resection.
|
22.5 Neoadjuvant Rectal (NAR) score
Standard Deviation 10.7
|
15.0 Neoadjuvant Rectal (NAR) score
Standard Deviation 0.0
|
17.0 Neoadjuvant Rectal (NAR) score
Standard Deviation 22.5
|
—
|
Adverse Events
Dosing Group 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dosing Group 2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Dosing Group 3
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Dosing Group 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dosing Group 1
n=2 participants at risk
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 2
n=4 participants at risk
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*). 3 x maintenance doses post-chemoradiation (low-low-low\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 3
n=6 participants at risk
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*). 3 x maintenance doses post-chemoradiation (low-high-high\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 4
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-high-high\*). 2 x concurrent doses on week 1, days 1 and 5 of chemoradiation (high-high\*). 3 x maintenance doses post-chemoradiation (low-high-high\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
|---|---|---|---|---|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
General disorders
Peripheral swelling
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
Other adverse events
| Measure |
Dosing Group 1
n=2 participants at risk
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 2
n=4 participants at risk
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*). 3 x maintenance doses post-chemoradiation (low-low-low\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 3
n=6 participants at risk
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-low-low\*). 3 x maintenance doses post-chemoradiation (low-high-high\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
Dosing Group 4
* Chemotherapy: 900 mg/m2 capecitabine twice daily, Mon-Fri (on radiotherapy days) for 5 weeks, except on days patients received enadenotucirev.
* Radiotherapy: 50 Gy in 25 fractions.
* Enadenotucirev: 3 x loading doses pre-chemoradiation (low-high-high\*). 2 x concurrent doses on week 1, days 1 and 5 of chemoradiation (high-high\*). 3 x maintenance doses post-chemoradiation (low-high-high\*).
* Low = 1x10\^12 viral particles High = 3x10\^12 viral particles
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
1/2 • Number of events 4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
General disorders
Chest discomfort
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Nervous system disorders
Dysgeusia
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
50.0%
2/4 • Number of events 4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
50.0%
3/6 • Number of events 6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
50.0%
2/4 • Number of events 2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
General disorders
Chills
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
50.0%
2/4 • Number of events 4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
83.3%
5/6 • Number of events 9 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
83.3%
5/6 • Number of events 5 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
General disorders
Influenza like illness
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
General disorders
Pain
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
General disorders
Peripheral swelling
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
33.3%
2/6 • Number of events 3 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Infections and infestations
Cystitis
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
33.3%
2/6 • Number of events 2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
General disorders
Headache
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
33.3%
2/6 • Number of events 2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Nervous system disorders
Neuropathy peripheral
|
100.0%
2/2 • Number of events 2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Psychiatric disorders
Tension
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
33.3%
2/6 • Number of events 2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Renal and urinary disorders
Micturition urgency
|
100.0%
2/2 • Number of events 2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Renal and urinary disorders
Polyuria
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Reproductive system and breast disorders
Dysparaeunia
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Reproductive system and breast disorders
Pelvic pain
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Reproductive system and breast disorders
Testicular pain
|
50.0%
1/2 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
25.0%
1/4 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/6 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Vascular disorders
Hot flush
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/2 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
0.00%
0/4 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
—
0/0 • Adverse events were monitored from the time patients consented to the trial until they completed their 4-6 weeks post-surgery visit (minimum duration 18 weeks).
Dosing group 4 was a planned schedule of treatment per protocol. However, the data collected during the trial, did not warrant escalation to this schedule, therefore there were no participants registered to this dosing group and thus, no patients were at risk in this group and adverse events were collected.
|
Additional Information
CEDAR Trial Manager, Oncology Clinical Trials Office (OCTO)
University of Oxford
Phone: 01865 617085
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place