Trial Outcomes & Findings for Study of Weekly Radiotherapy for Bladder Cancer (NCT NCT01810757)

NCT ID: NCT01810757

Last Updated: 2026-01-15

Results Overview

Non-GU CTCAE G3+ treatment-related toxicity occurring within the first 3 months of radiotherapy completing

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

65 participants

Primary outcome timeframe

12 weeks from completion of radiotherapy

Results posted on

2026-01-15

Participant Flow

Participant milestones

Participant milestones
Measure
Standard Planning
Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
Adaptive Planning
Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
Overall Study
STARTED
32
33
Overall Study
COMPLETED
32
33
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Weekly Radiotherapy for Bladder Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Standard Planning
n=32 Participants
Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
Adaptive Planning
n=33 Participants
Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
Total
n=65 Participants
Total of all reporting groups
Multiple tumours
Yes
6 Participants
n=9 Participants
7 Participants
n=6 Participants
13 Participants
n=9 Participants
Age, Continuous
84.8 years
n=9 Participants
84.1 years
n=6 Participants
84.5 years
n=9 Participants
Sex: Female, Male
Female
8 Participants
n=9 Participants
13 Participants
n=6 Participants
21 Participants
n=9 Participants
Sex: Female, Male
Male
24 Participants
n=9 Participants
20 Participants
n=6 Participants
44 Participants
n=9 Participants
Region of Enrollment
United Kingdom
32 participants
n=9 Participants
33 participants
n=6 Participants
65 participants
n=9 Participants
Extent of resection
Biopsy
10 Participants
n=9 Participants
10 Participants
n=6 Participants
20 Participants
n=9 Participants
Extent of resection
Partial resection
10 Participants
n=9 Participants
13 Participants
n=6 Participants
23 Participants
n=9 Participants
Extent of resection
Full resection
11 Participants
n=9 Participants
9 Participants
n=6 Participants
20 Participants
n=9 Participants
Extent of resection
Unobtainable
1 Participants
n=9 Participants
1 Participants
n=6 Participants
2 Participants
n=9 Participants
Multiple tumours
No
26 Participants
n=9 Participants
26 Participants
n=6 Participants
52 Participants
n=9 Participants
Histological tumour type
Urothelial
31 Participants
n=9 Participants
32 Participants
n=6 Participants
63 Participants
n=9 Participants
Histological tumour type
Non-urothelial
1 Participants
n=9 Participants
1 Participants
n=6 Participants
2 Participants
n=9 Participants
Grade
Grade 1
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
Grade
Grade 2
1 Participants
n=9 Participants
0 Participants
n=6 Participants
1 Participants
n=9 Participants
Grade
Grade 3
31 Participants
n=9 Participants
33 Participants
n=6 Participants
64 Participants
n=9 Participants
Carcinoma in situ (CIS) present
Yes
9 Participants
n=9 Participants
11 Participants
n=6 Participants
20 Participants
n=9 Participants
Carcinoma in situ (CIS) present
No
22 Participants
n=9 Participants
22 Participants
n=6 Participants
44 Participants
n=9 Participants
Carcinoma in situ (CIS) present
Unobtainable
1 Participants
n=9 Participants
0 Participants
n=6 Participants
1 Participants
n=9 Participants
Clinical stage
T1
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
Clinical stage
T2
24 Participants
n=9 Participants
21 Participants
n=6 Participants
45 Participants
n=9 Participants
Clinical stage
T3a
1 Participants
n=9 Participants
5 Participants
n=6 Participants
6 Participants
n=9 Participants
Clinical stage
T3b
5 Participants
n=9 Participants
5 Participants
n=6 Participants
10 Participants
n=9 Participants
Clinical stage
T4a
2 Participants
n=9 Participants
2 Participants
n=6 Participants
4 Participants
n=9 Participants
Age adjusted Charlson Comorbidity index score
5
1 Participants
n=9 Participants
0 Participants
n=6 Participants
1 Participants
n=9 Participants
Age adjusted Charlson Comorbidity index score
6
14 Participants
n=9 Participants
13 Participants
n=6 Participants
27 Participants
n=9 Participants
Age adjusted Charlson Comorbidity index score
7
11 Participants
n=9 Participants
5 Participants
n=6 Participants
16 Participants
n=9 Participants
Age adjusted Charlson Comorbidity index score
8
4 Participants
n=9 Participants
6 Participants
n=6 Participants
10 Participants
n=9 Participants
Age adjusted Charlson Comorbidity index score
9
2 Participants
n=9 Participants
8 Participants
n=6 Participants
10 Participants
n=9 Participants
Age adjusted Charlson Comorbidity index score
10
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
Age adjusted Charlson Comorbidity index score
11
0 Participants
n=9 Participants
1 Participants
n=6 Participants
1 Participants
n=9 Participants

PRIMARY outcome

Timeframe: 12 weeks from completion of radiotherapy

Population: Evaluable patient population: This population contains all randomised patients who have received at least one fraction of radiotherapy and are evaluable for the primary endpoint of acute toxicity (i.e. toxicity reported up to 3 months post radiotherapy). Patients had been reviewed for evaluability by the independent Trial steering committee (TSC) blinded to planning method and the TSC's view on evaluability for the primary endpoint has been used to define the evaluable patient population.

Non-GU CTCAE G3+ treatment-related toxicity occurring within the first 3 months of radiotherapy completing

Outcome measures

Outcome measures
Measure
Standard Planning
n=30 Participants
Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
Adaptive Planning
n=33 Participants
Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
Proportion of Patients Experiencing Severe Acute Non-genitourinary Side Effects Following Radiotherapy.
4 Participants
2 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Including only those who had an assessment at 3 months

Presence of cancer in the bladder 3 months after treatment. Presented as the proportion of all patients regardless of treatment allocation (standard and adaptive combined) having evidence of residual tumour.

Outcome measures

Outcome measures
Measure
Standard Planning
n=23 Participants
Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
Adaptive Planning
n=25 Participants
Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
Local Disease Control Rate
17 Participants
22 Participants

SECONDARY outcome

Timeframe: Event-free survival estimates at 12 months and 24 months are reported.

Population: Intention to treat population. It was pre-planned in the SAP to combine the two treatment arms together because there is insufficient statistical power to detect clinically meaningful differences.

From randomisation to a maximum follow-up of 30 months. It was pre-planned in the SAP to combine the two treatment arms together because there is insufficient statistical power to detect clinically meaningful differences.

Outcome measures

Outcome measures
Measure
Standard Planning
n=65 Participants
Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
Adaptive Planning
Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
Time to Local Disease Progression
KM 12 months
71.7 percentage event-free
Interval 55.9 to 82.6
Time to Local Disease Progression
KM 24 months
47.3 percentage event-free
Interval 29.6 to 63.1

SECONDARY outcome

Timeframe: Event-free survival estimates at 12 months and 24months are reported.

Population: Intention to treat population. It was pre-planned in the SAP to combine the two treatment arms together because there is insufficient statistical power to detect clinically meaningful differences.

From randomisation to maximum follow-up of 56 months. It was pre-planned in the SAP to combine the two treatment arms together because there is insufficient statistical power to detect clinically meaningful differences.

Outcome measures

Outcome measures
Measure
Standard Planning
n=65 Participants
Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
Adaptive Planning
Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
Overall Survival
KM 12 months
61.5 percentage surviving
Interval 48.6 to 72.1
Overall Survival
KM 24 months
46.2 percentage surviving
Interval 33.8 to 57.7

SECONDARY outcome

Timeframe: 3 months from the completion of radiotherapy

Population: Including those with 3 month follow up acute toxicity available. Frequency threshold for reporting: Renal and urinary symptom reported in 20% or more of patients with symptoms/toxicity reported.

Assessed by looking at change in symptom scores from pre to post radiotherapy. The number of patients with post-radiotherapy scores lower than their baseline score have been used to calculate the control rate of presenting symptoms and is presented separately for the two randomisation groups.

Outcome measures

Outcome measures
Measure
Standard Planning
n=27 Participants
Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
Adaptive Planning
n=29 Participants
Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
The Control Rate of Presenting Symptoms
Nocturia
3 participants
5 participants
The Control Rate of Presenting Symptoms
Frequency/Urgency
5 participants
7 participants
The Control Rate of Presenting Symptoms
Urinary incontinence
4 participants
4 participants
The Control Rate of Presenting Symptoms
Cystitis
3 participants
8 participants
The Control Rate of Presenting Symptoms
Haematuria
4 participants
8 participants

SECONDARY outcome

Timeframe: End of treatment, treatment is given over 6 weeks

Population: ITT

Assessed by the number of small or large plans being selected rather than the medium plan for patients in the adaptive planning group. The denominator will be the total number of fractions received in the adaptive planning group.

Outcome measures

Outcome measures
Measure
Standard Planning
n=193 Fractions
Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
Adaptive Planning
Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
The Proportion of Fractions Benefiting From Adaptive Planning
76 Fractions

Adverse Events

Adaptive Planning

Serious events: 9 serious events
Other events: 33 other events
Deaths: 0 deaths

Standard Planning

Serious events: 11 serious events
Other events: 32 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Adaptive Planning
n=33 participants at risk
Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
Standard Planning
n=32 participants at risk
Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
Gastrointestinal disorders
Abdominal pain
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Blood and lymphatic system disorders
Anaemia
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
6.2%
2/32 • Number of events 2 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
6.2%
2/32 • Number of events 2 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Blood creatinine increased
12.1%
4/33 • Number of events 4 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
6.2%
2/32 • Number of events 2 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Blood phosphorus decreased
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Blood potassium increased
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Blood sodium decreased
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Blood urea increased
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Infections and infestations
Bronchopneumonia
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Cardiac disorders
Cardiac failure congestive
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders
Constipation
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders
Dehydration
9.1%
3/33 • Number of events 3 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders
Diarrhoea
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
General disorders
Fatigue
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
6.2%
2/32 • Number of events 2 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Hydronephrosis
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders
Hypercalcaemia
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders
Hyperkalaemia
6.1%
2/33 • Number of events 2 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders
Hyponatraemia
9.1%
3/33 • Number of events 4 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Musculoskeletal and connective tissue disorders
Mobility decreased
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders
Nausea
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Reproductive system and breast disorders
Perineal pain
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Infections and infestations
Pneumonia
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Renal failure
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Renal failure acute
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Renal failure chronic
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Infections and infestations
Sepsis
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Infections and infestations
Urinary tract infection
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Weight decreased
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M

Other adverse events

Other adverse events
Measure
Adaptive Planning
n=33 participants at risk
Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
Standard Planning
n=32 participants at risk
Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
Gastrointestinal disorders
Abdominal pain
45.5%
15/33 • Number of events 42 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
40.6%
13/32 • Number of events 35 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Alanine aminotransferase increased
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 2 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Blood and lymphatic system disorders
Anaemia
18.2%
6/33 • Number of events 13 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
25.0%
8/32 • Number of events 27 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Aspartate aminotransferase increased
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Musculoskeletal and connective tissue disorders
Back pain
3.0%
1/33 • Number of events 2 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
12.5%
4/32 • Number of events 11 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Bladder obstruction
21.2%
7/33 • Number of events 8 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
34.4%
11/32 • Number of events 34 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Bladder pain
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 3 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Bladder spasm
27.3%
9/33 • Number of events 17 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
46.9%
15/32 • Number of events 41 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Blood albumin decreased
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Blood alkaline phosphatase increased
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Blood bilirubin decreased
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 3 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Blood creatinine increased
30.3%
10/33 • Number of events 28 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
43.8%
14/32 • Number of events 62 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Blood phosphorus decreased
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 5 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Blood potassium increased
6.1%
2/33 • Number of events 4 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Blood sodium decreased
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 2 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Blood urea increased
9.1%
3/33 • Number of events 13 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
9.4%
3/32 • Number of events 11 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Infections and infestations
Bronchopneumonia
6.1%
2/33 • Number of events 2 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Cardiac disorders
Cardiac failure congestive
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Cardiac disorders
Cardiorenal syndrome
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Infections and infestations
Cellulitis
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
General disorders and administration site conditions
Chills
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Psychiatric disorders
Confusional state
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
6.2%
2/32 • Number of events 2 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders
Constipation
48.5%
16/33 • Number of events 58 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
68.8%
22/32 • Number of events 96 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Respiratory, thoracic and mediastinal disorders
Cough
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Cystitis
63.6%
21/33 • Number of events 77 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
65.6%
21/32 • Number of events 63 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders
Decreased appetite
48.5%
16/33 • Number of events 51 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
53.1%
17/32 • Number of events 57 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders
Dehydration
27.3%
9/33 • Number of events 34 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
18.8%
6/32 • Number of events 9 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders
Diarrhoea
66.7%
22/33 • Number of events 64 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
71.9%
23/32 • Number of events 50 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Nervous system disorders
Dizziness
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 2 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders
Dry mouth
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 5 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Respiratory, thoracic and mediastinal disorders
Dyspnoea
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Dysuria
12.1%
4/33 • Number of events 17 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 8 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders
Faecal incontinence
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
General disorders and administration site conditions
Fatigue
93.9%
31/33 • Number of events 168 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
96.9%
31/32 • Number of events 188 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders
Frequent bowel movements
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Infections and infestations
Fungal infection
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Gamma-glutamyltransferase increased
6.1%
2/33 • Number of events 8 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
6.2%
2/32 • Number of events 4 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders
Gastrointestinal fistula
6.1%
2/33 • Number of events 2 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders
Gastrointestinal obstruction
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Haematuria
48.5%
16/33 • Number of events 46 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
53.1%
17/32 • Number of events 44 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Injury, poisoning and procedural complications
Hip fracture
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Reproductive system and breast disorders
Hot flush
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 3 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Hydronephrosis
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 3 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders
Hypercalcaemia
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders
Hyperkalaemia
12.1%
4/33 • Number of events 7 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
6.2%
2/32 • Number of events 6 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders
Hypernatraemia
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders
Hyperuricaemia
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders
Hyponatraemia
9.1%
3/33 • Number of events 5 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
6.2%
2/32 • Number of events 6 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
9.1%
3/33 • Number of events 3 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
6.2%
2/32 • Number of events 3 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Lymphocyte count decreased
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Vascular disorders
Lymphoedema
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Micturition disorder
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Micturition urgency
9.1%
3/33 • Number of events 4 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Musculoskeletal and connective tissue disorders
Mobility decreased
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Cardiac disorders
Myocardial infarction
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders
Nausea
24.2%
8/33 • Number of events 24 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
18.8%
6/32 • Number of events 14 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Neutrophil count increased
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Nocturia
93.9%
31/33 • Number of events 209 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
87.5%
28/32 • Number of events 193 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
General disorders and administration site conditions
Non-cardiac chest pain
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Pelvic pain
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
6.2%
2/32 • Number of events 2 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Reproductive system and breast disorders
Perineal pain
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Platelet count decreased
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Infections and infestations
Pneumonia
6.1%
2/33 • Number of events 2 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Pollakiuria
90.9%
30/33 • Number of events 182 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
87.5%
28/32 • Number of events 175 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders
Proctitis
15.2%
5/33 • Number of events 7 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
18.8%
6/32 • Number of events 9 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Renal colic
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Renal failure
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
6.2%
2/32 • Number of events 2 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Renal failure acute
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
6.2%
2/32 • Number of events 2 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Renal failure chronic
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 2 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Nervous system disorders
Restless legs syndrome
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 7 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Infections and infestations
Sepsis
6.1%
2/33 • Number of events 3 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Skin and subcutaneous tissue disorders
Skin lesion
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary bladder adenoma
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Urinary hesitation
9.1%
3/33 • Number of events 12 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 2 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Urinary incontinence
57.6%
19/33 • Number of events 75 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
50.0%
16/32 • Number of events 62 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Urinary retention
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
9.4%
3/32 • Number of events 11 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Infections and infestations
Urinary tract infection
18.2%
6/33 • Number of events 12 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
12.5%
4/32 • Number of events 8 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders
Urinary tract obstruction
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
6.2%
2/32 • Number of events 4 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Infections and infestations
Urosepsis
3.0%
1/33 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
0.00%
0/32 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders
Vomiting
21.2%
7/33 • Number of events 11 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
6.2%
2/32 • Number of events 3 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
Weight decreased
27.3%
9/33 • Number of events 14 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
31.2%
10/32 • Number of events 24 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations
White blood cell count increased
0.00%
0/33 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
3.1%
1/32 • Number of events 1 • Adverse event data was collected up to 24 months.
Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M

Additional Information

Professor Emma Hall (Co-Director of ICR-CTSU)

The Institute of Cancer Research, Clinical Trials and Statistics Unit (ICR-CTSU)

Phone: +44 (0)208 722

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place