Trial Outcomes & Findings for Palliative Thoracic Radiotherapy Plus BKM120 (NCT NCT02128724)
NCT ID: NCT02128724
Last Updated: 2019-08-01
Results Overview
The maximum tolerated dose (MTD) was defined as the highest dose at which no more than 1 of 6 evaluable patients or 0 of 3 evaluable patients experience a dose limiting toxicity (DLT). The study was carried out using a 3+3 dose escalation design. DLTs were defined per NCI CTCAE v 4.0. The following were considered DLT if they occur at any point whilst the patient is on study: 1) Any ≥ grade 3 non-haematological toxicity (excluding nausea, vomiting or diarrhoea) that requires hospital admission or which does not resolve to ≤ grade 2 within 7 consecutive days of optimal treatment. 2) Any ≥ grade 3 nausea, vomiting or diarrhoea will be considered DLT only if any of them persist for \>48 hours despite maximum supportive care. 3) ≥ Grade 3 pneumonitis 4) Any ≥ Grade 4 haematological toxicity. 5) Mood deterioration from baseline. DLT will be any grade ≥3 mood change if BL score of 2. DLT will be any grade ≥2 mood change if baseline score of ≤ 1.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
8 weeks (10 weeks cohort 4 - this cohort was not opened)
Results posted on
2019-08-01
Participant Flow
Participant milestones
| Measure |
Cohort 1: 50mg Buparlisib
These patients were treated with 50mg buparlisib OD for a total of fourteen days. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
BKM120: BKM120/buparlisib is a highly specific inhibitor of phosphatidylinositol 3-kinase (PI3K). BKM120 is supplied as 10mg and 50mg hard gelatin capsules.
|
Cohort 2: 80mg Buparlisib
These patients were treated with 80mg buparlisib OD for a total of fourteen days. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
BKM120: BKM120/buparlisib is a highly specific inhibitor of phosphatidylinositol 3-kinase (PI3K). BKM120 is supplied as 10mg and 50mg hard gelatin capsules.
|
Cohort 3: 100mg Buparlisib
These patients were treated with 100mg buparlisib OD for a total of fourteen days. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
BKM120: BKM120/buparlisib is a highly specific inhibitor of phosphatidylinositol 3-kinase (PI3K). BKM120 is supplied as 10mg and 50mg hard gelatin capsules.
|
100mg Buparlisib Expansion Cohort
These patients were treated with 100mg buparlisib OD for a total of fourteen days, after 100mg buparlisib OD was determined to be the MTD. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
BKM120: BKM120/buparlisib is a highly specific inhibitor of phosphatidylinositol 3-kinase (PI3K). BKM120 is supplied as 10mg and 50mg hard gelatin capsules.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
3
|
10
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
3
|
Reasons for withdrawal
| Measure |
Cohort 1: 50mg Buparlisib
These patients were treated with 50mg buparlisib OD for a total of fourteen days. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
BKM120: BKM120/buparlisib is a highly specific inhibitor of phosphatidylinositol 3-kinase (PI3K). BKM120 is supplied as 10mg and 50mg hard gelatin capsules.
|
Cohort 2: 80mg Buparlisib
These patients were treated with 80mg buparlisib OD for a total of fourteen days. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
BKM120: BKM120/buparlisib is a highly specific inhibitor of phosphatidylinositol 3-kinase (PI3K). BKM120 is supplied as 10mg and 50mg hard gelatin capsules.
|
Cohort 3: 100mg Buparlisib
These patients were treated with 100mg buparlisib OD for a total of fourteen days. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
BKM120: BKM120/buparlisib is a highly specific inhibitor of phosphatidylinositol 3-kinase (PI3K). BKM120 is supplied as 10mg and 50mg hard gelatin capsules.
|
100mg Buparlisib Expansion Cohort
These patients were treated with 100mg buparlisib OD for a total of fourteen days, after 100mg buparlisib OD was determined to be the MTD. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
BKM120: BKM120/buparlisib is a highly specific inhibitor of phosphatidylinositol 3-kinase (PI3K). BKM120 is supplied as 10mg and 50mg hard gelatin capsules.
|
|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dose Escalation Phase: Cohort 1
n=4 Participants
Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 2
n=4 Participants
Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 3
n=3 Participants
Patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Expansion Phase
n=10 Participants
Patients treated at 100mg buparlisib once daily for a total of fourteen days after the MTD had been established at 100mg buparlisib. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64 years
n=4 Participants
|
72 years
n=4 Participants
|
68 years
n=3 Participants
|
68 years
n=10 Participants
|
69 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
8 Participants
n=10 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=10 Participants
|
7 Participants
n=21 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=4 Participants
|
4 participants
n=4 Participants
|
3 participants
n=3 Participants
|
10 participants
n=10 Participants
|
21 participants
n=21 Participants
|
|
Stage of Disease IV
|
4 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
10 Participants
n=10 Participants
|
21 Participants
n=21 Participants
|
|
Gross tumour volume
|
111 mL
n=4 Participants
|
135 mL
n=4 Participants
|
54 mL
n=3 Participants
|
99 mL
n=10 Participants
|
101 mL
n=21 Participants
|
|
Histology: Adenocarcinoma
|
3 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
6 Participants
n=10 Participants
|
11 Participants
n=21 Participants
|
|
Histology: Squamous cell
|
1 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=10 Participants
|
10 Participants
n=21 Participants
|
|
Prior Chemotherapy Treatment
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
7 Participants
n=10 Participants
|
12 Participants
n=21 Participants
|
|
Prior surgical treatment
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=21 Participants
|
|
Prior Extra Thoracic Radiotherapy Treatment
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
ECOG PS Score 0
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
ECOG PS Score 1
|
4 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=10 Participants
|
15 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 8 weeks (10 weeks cohort 4 - this cohort was not opened)Population: The Primary Dose Escalation analysis (the declaration of MTD) included all patients completing 14 days of buparlisib treatment and 56 days of evaluation or patients who withdrew early after experiencing DLT.
The maximum tolerated dose (MTD) was defined as the highest dose at which no more than 1 of 6 evaluable patients or 0 of 3 evaluable patients experience a dose limiting toxicity (DLT). The study was carried out using a 3+3 dose escalation design. DLTs were defined per NCI CTCAE v 4.0. The following were considered DLT if they occur at any point whilst the patient is on study: 1) Any ≥ grade 3 non-haematological toxicity (excluding nausea, vomiting or diarrhoea) that requires hospital admission or which does not resolve to ≤ grade 2 within 7 consecutive days of optimal treatment. 2) Any ≥ grade 3 nausea, vomiting or diarrhoea will be considered DLT only if any of them persist for \>48 hours despite maximum supportive care. 3) ≥ Grade 3 pneumonitis 4) Any ≥ Grade 4 haematological toxicity. 5) Mood deterioration from baseline. DLT will be any grade ≥3 mood change if BL score of 2. DLT will be any grade ≥2 mood change if baseline score of ≤ 1.
Outcome measures
| Measure |
Dose Escalation Phase: Cohort 1
n=3 Participants
Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 2
n=3 Participants
Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 3
n=3 Participants
Patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
|---|---|---|---|
|
Dose Escalation Analysis: Number of DLTs Observed in Evaluable Patients
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 8 weeks (10 weeks cohort 4 - this cohort was not opened)Population: The safety and tolerability post-treatment analysis was based on all patients who received at least one MTD dose of buparlisib (n = 21).
Adverse events (AEs) and Serious Adverse Events (SAEs) were also analysed for frequency. For further details, please consult the AEs/SAEs section.
Outcome measures
| Measure |
Dose Escalation Phase: Cohort 1
n=4 Participants
Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 2
n=4 Participants
Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 3
n=13 Participants
Patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
|---|---|---|---|
|
Safety and Tolerability Analysis: Patients With Buparlisib Related Adverse Events
Patients with Serious Adverse Events (SAEs)
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Safety and Tolerability Analysis: Patients With Buparlisib Related Adverse Events
Patients with Grade >=3 Adverse Events
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Safety and Tolerability Analysis: Patients With Buparlisib Related Adverse Events
Patients discontinued because of SAEs
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability Analysis: Patients With Buparlisib Related Adverse Events
Patients discontinued because of AEs
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days -1 and 8Population: The tumour hypoxia analysis involved all patients who had a pair of interpretable 18F-Miso PET scans.
18F-Miso is a radiotracer that selectively accumulates in hypoxic tissues. 18F-Miso PET-CT scans are able to non-invasively image tumour hypoxia. A 18F-Miso PET-CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour hypoxia due to buparlisib treatment. For tumour hypoxia, a patient is classified as a 'responder' if there is evidence of a 10% or greater reduction in retained F-Misonidazole. Hypoxia was measured using TBRmean or TBRvolume (tumour-to-blood ratio).
Outcome measures
| Measure |
Dose Escalation Phase: Cohort 1
n=3 Participants
Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 2
n=3 Participants
Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 3
n=9 Participants
Patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
|---|---|---|---|
|
Changes in 18F-Misonidazole Uptake as Detected by PET-CT Scans: Response
Responder
|
0 Participants
|
3 Participants
|
7 Participants
|
|
Changes in 18F-Misonidazole Uptake as Detected by PET-CT Scans: Response
Non-Responder
|
3 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Days -1 and 8Population: The tumour perfusion analysis involved all patients who had a pair of interpretable pCT scans.
Perfusion CT is a technique used to study the vasculature within tumours and other tissues. It is non-invasive and readily incorporated into existing CT protocols using conventional contrast agents. A perfusion CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour physiology due to buparlisib treatment.
Outcome measures
| Measure |
Dose Escalation Phase: Cohort 1
n=3 Participants
Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 2
n=3 Participants
Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 3
n=8 Participants
Patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
|---|---|---|---|
|
Blood Flow at Days -1 and 8 as Detected by Perfusion CT
pCT blood flow 1st scan
|
64.2 mL/100g/min
Interval 42.0 to 88.4
|
102.2 mL/100g/min
Interval 55.8 to 106.2
|
63.9 mL/100g/min
Interval 51.4 to 92.9
|
|
Blood Flow at Days -1 and 8 as Detected by Perfusion CT
pCT blood flow 2nd scan
|
60.2 mL/100g/min
Interval 42.6 to 118.5
|
63.9 mL/100g/min
Interval 51.4 to 92.9
|
64.5 mL/100g/min
Interval 41.6 to 86.9
|
SECONDARY outcome
Timeframe: Days -1 and 8Population: The tumour hypoxia analysis involved all patients who had a pair of interpretable PET scans.
18F-Miso is a radiotracer that selectively accumulates in hypoxic tissues. 18F-Miso PET-CT scans are able to non-invasively image tumour hypoxia. A 18F-Miso PET-CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment. Tumour to blood volume ratio ("TBR volume") is measured by summing the number of tumour/node/metastases voxels with a value greater than or equal to 1.4.
Outcome measures
| Measure |
Dose Escalation Phase: Cohort 1
n=3 Participants
Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 2
n=3 Participants
Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 3
n=9 Participants
Patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
|---|---|---|---|
|
Tumour-to-blood Volume Ratio in 18F-Misonidazole Uptake as Detected by Day -1 and Day 8 PET-CT Scans, to Investigate if Buparlisib Alters Hypoxia
First scan
|
44.4 Tumour to blood volume ratio
Interval 0.4 to 239.0
|
51.3 Tumour to blood volume ratio
Interval 1.3 to 99.5
|
33.1 Tumour to blood volume ratio
Interval 6.9 to 43.7
|
|
Tumour-to-blood Volume Ratio in 18F-Misonidazole Uptake as Detected by Day -1 and Day 8 PET-CT Scans, to Investigate if Buparlisib Alters Hypoxia
Second scan
|
47.6 Tumour to blood volume ratio
Interval 0.4 to 233.0
|
42.2 Tumour to blood volume ratio
Interval 1.1 to 75.6
|
25.4 Tumour to blood volume ratio
Interval 4.9 to 42.0
|
SECONDARY outcome
Timeframe: Days -1 and 8Population: The tumour perfusion analysis involved all patients who had a pair of interpretable pCT scans.
Perfusion CT is a technique used to study the vasculature within tumours and other tissues. It is non-invasive and readily incorporated into existing CT protocols using conventional contrast agents. A perfusion CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour physiology due to buparlisib treatment. For tumour perfusion, a patient is classified as 'responder' if blood flow (BF) and/or blood volume (BV) is increased and/or mean transit time (MTT) is reduced from baseline measurements by more than 25%.
Outcome measures
| Measure |
Dose Escalation Phase: Cohort 1
n=3 Participants
Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 2
n=3 Participants
Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 3
n=8 Participants
Patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
|---|---|---|---|
|
Changes in Blood Flow as Detected by Perfusion CT: Response
Responder
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Changes in Blood Flow as Detected by Perfusion CT: Response
Non-Responder
|
1 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Days -1 and 8Population: The tumour perfusion analysis involved all patients who had a pair of interpretable pCT scans.
Perfusion CT is a technique used to study the vasculature within tumours and other tissues. It is non-invasive and readily incorporated into existing CT protocols using conventional contrast agents. A perfusion CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour physiology (blood flow) due to buparlisib treatment, and the percentage change between both scans calculated.
Outcome measures
| Measure |
Dose Escalation Phase: Cohort 1
n=3 Participants
Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 2
n=3 Participants
Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 3
n=8 Participants
Patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
|---|---|---|---|
|
Percentage Change in Blood Flow as Detected by Perfusion CT at Days -1 and 8
|
1.4 % change in mL/100g/min
Interval -6.2 to 34.0
|
-17.5 % change in mL/100g/min
Interval -35.1 to 11.0
|
-15.0 % change in mL/100g/min
Interval -33.7 to 16.7
|
SECONDARY outcome
Timeframe: Days -1 and 8Population: The tumour hypoxia analysis involved all patients who had a pair of interpretable PET scans.
18F-Miso is a radiotracer that selectively accumulates in hypoxic tissues. 18F-Miso PET-CT scans are able to non-invasively image tumour hypoxia. A 18F-Miso PET-CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour hypoxia due to buparlisib treatment. Hypoxia was measured using TBRmean and TBRvolume (tumour-to-blood ratio mean, tumour-to-blood ratio volume). TBR mean is measured by dividing all tumour/node/metastases voxels by the mean value of the descending aorta activity concentration.
Outcome measures
| Measure |
Dose Escalation Phase: Cohort 1
n=3 Participants
Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 2
n=3 Participants
Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 3
n=9 Participants
Patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
|---|---|---|---|
|
Tumour-to-blood Mean Ratio in 18F-Misonidazole Uptake as Detected by PET-CT Scans, to Investigate if Buparlisib Alters Hypoxia
Second scan
|
1.41 Tumour to blood mean ratio
Interval 1.03 to 1.47
|
1.07 Tumour to blood mean ratio
Interval 0.91 to 1.37
|
1.17 Tumour to blood mean ratio
Interval 1.11 to 1.25
|
|
Tumour-to-blood Mean Ratio in 18F-Misonidazole Uptake as Detected by PET-CT Scans, to Investigate if Buparlisib Alters Hypoxia
First scan
|
1.34 Tumour to blood mean ratio
Interval 0.89 to 1.39
|
1.2 Tumour to blood mean ratio
Interval 0.94 to 1.42
|
1.23 Tumour to blood mean ratio
Interval 1.11 to 1.25
|
SECONDARY outcome
Timeframe: Days -1 and 8Population: The tumour hypoxia analysis involved all patients who had a pair of interpretable PET scans.
18F-Miso is a radiotracer that selectively accumulates in hypoxic tissues. 18F-Miso PET-CT scans are able to non-invasively image tumour hypoxia. A 18F-Miso PET-CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour hypoxia due to buparlisib treatment. The percentage change between the TBR volume for the 1st and 2nd scans was calculated. TBR volume is measured by summing the number of tumour/node/metastases voxels with a value greater than or equal to 1.4. Hypoxia was measured using TBRmean and TBRvolume (tumour-to-blood ratio mean, tumour-to-blood ratio volume).
Outcome measures
| Measure |
Dose Escalation Phase: Cohort 1
n=3 Participants
Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 2
n=3 Participants
Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 3
n=9 Participants
Patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
|---|---|---|---|
|
Tumour-to-blood Volume Ratio Percentage Changes Between Day -1 and Day 8 in 18F-Misonidazole Uptake as Detected by PET-CT Scans, to Investigate if Buparlisib Alters Hypoxia
|
7.1 % change in tumour to blood volume ratio
Interval -2.5 to 14.3
|
-17.6 % change in tumour to blood volume ratio
Interval -24.1 to 16.7
|
-19.9 % change in tumour to blood volume ratio
Interval -41.9 to 14.6
|
SECONDARY outcome
Timeframe: Days -1 and 8Population: The tumour perfusion analysis involved all patients who had a pair of interpretable pCT scans.
Perfusion CT is a technique used to study the vasculature within tumours and other tissues. It is non-invasive and readily incorporated into existing CT protocols using conventional contrast agents. A perfusion CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour physiology due to buparlisib treatment, and the % change between the 2 scans calculated.
Outcome measures
| Measure |
Dose Escalation Phase: Cohort 1
n=3 Participants
Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 2
n=3 Participants
Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 3
n=8 Participants
Patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
|---|---|---|---|
|
Percentage Changes in Blood Volume Between Day -1 and Day 8 as Detected by Perfusion CT
|
-11.1 % change in mL/100g
Interval -27.8 to 5.0
|
-25.0 % change in mL/100g
Interval -34.7 to 4.6
|
-21.2 % change in mL/100g
Interval -46.3 to 6.2
|
SECONDARY outcome
Timeframe: Days -1 and 8Population: The tumour perfusion analysis involved all patients who had a pair of interpretable pCT scans.
Perfusion CT is a technique used to study the vasculature within tumours and other tissues. It is non-invasive and readily incorporated into existing CT protocols using conventional contrast agents. A perfusion CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour physiology due to buparlisib treatment
Outcome measures
| Measure |
Dose Escalation Phase: Cohort 1
n=3 Participants
Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 2
n=3 Participants
Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 3
n=8 Participants
Patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
|---|---|---|---|
|
Blood Volume at Day -1 and Day 8 as Detected by Perfusion CT
pCT first scan
|
4.0 mL/100g
Interval 3.6 to 9.0
|
6.5 mL/100g
Interval 4.0 to 7.2
|
5.8 mL/100g
Interval 4.3 to 7.5
|
|
Blood Volume at Day -1 and Day 8 as Detected by Perfusion CT
pCT second scan
|
3.8 mL/100g
Interval 2.6 to 8.0
|
4.7 mL/100g
Interval 3.0 to 6.2
|
5.6 mL/100g
Interval 3.2 to 5.9
|
SECONDARY outcome
Timeframe: Days -1 and 8Population: The tumour perfusion analysis involved all patients who had a pair of interpretable pCT scans.
Perfusion CT is a technique used to study the vasculature within tumours and other tissues. It is non-invasive and readily incorporated into existing CT protocols using conventional contrast agents. A perfusion CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour physiology (blood flow) due to buparlisib treatment.
Outcome measures
| Measure |
Dose Escalation Phase: Cohort 1
n=3 Participants
Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 2
n=3 Participants
Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 3
n=8 Participants
Patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
|---|---|---|---|
|
Mean Transit Time as Detected by Perfusion CT at Days -1 and 8
pCT first scan
|
8.6 seconds
Interval 6.3 to 11.2
|
7.8 seconds
Interval 6.4 to 8.1
|
7.4 seconds
Interval 6.6 to 8.0
|
|
Mean Transit Time as Detected by Perfusion CT at Days -1 and 8
pCT second scan
|
6.2 seconds
Interval 5.8 to 8.3
|
6.2 seconds
Interval 6.1 to 10.1
|
6.7 seconds
Interval 5.7 to 7.5
|
SECONDARY outcome
Timeframe: Days -1 and 8Population: The tumour perfusion analysis involved all patients who had a pair of interpretable pCT scans.
Perfusion CT is a technique used to study the vasculature within tumours and other tissues. It is non-invasive and readily incorporated into existing CT protocols using conventional contrast agents. A perfusion CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour physiology (blood flow) due to buparlisib treatment, and the % change between the 2 scans was calculated.
Outcome measures
| Measure |
Dose Escalation Phase: Cohort 1
n=3 Participants
Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 2
n=3 Participants
Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 3
n=8 Participants
Patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
|---|---|---|---|
|
Percentage Change in Mean Transit Time as Detected by Perfusion CT at Days -1 and 8
|
-25.9 % change in seconds
Interval -27.9 to 7.9
|
-3.1 % change in seconds
Interval -21.89 to 24.7
|
-12.6 % change in seconds
Interval -17.8 to 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, days 8, 14, 28 and 56Population: No scoring was performed, as on staining it was determined that the inter- and intra- participant variability seen would prevent any meaningful conclusions from being drawn.
The levels of phospho-Akt expression in normal tissues may reflect the efficacy of BKM120. Changes in phospho-Akt expression will be monitored during the trial using PBMCs taken during the trial. Reductions in phospho-Akt expression of PBMC's following BKM120 treatment were to be correlated with changes observed with the functional imaging investigations; however it was not possible to draw any meaningful conclusions due to huge inter- and intra- participant variability seen on staining (no scoring was performed).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Archival sample taken before trial entryPopulation: Where possible, tissue was obtained from trial participants' diagnostic samples.
Exploratory studies aimed to correlate response to buparlisib with activation of specific molecular pathways present in the archived, diagnostic, tumour biopsy sample.
Outcome measures
| Measure |
Dose Escalation Phase: Cohort 1
n=2 Participants
Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 2
n=3 Participants
Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 3
n=4 Participants
Patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
|---|---|---|---|
|
Measure Tumour PTEN (Phosphatase and Tensin Homolog Gene) Levels
Positive
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Measure Tumour PTEN (Phosphatase and Tensin Homolog Gene) Levels
Negative
|
1 Participants
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Archival sample taken before trial entryPopulation: Where possible, tissue was obtained from the trial participants' clinical diagnostic samples.
Exploratory studies will aim to correlate response to BKM120 with activation of specific molecular pathways present in the archived, diagnostic, tumour biopsy sample.
Outcome measures
| Measure |
Dose Escalation Phase: Cohort 1
n=3 Participants
Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 2
n=3 Participants
Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 3
n=9 Participants
Patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
|---|---|---|---|
|
Measure Tumour PRAS40 Levels
Positive
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Measure Tumour PRAS40 Levels
Negative
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Measure Tumour PRAS40 Levels
Insufficient tissue
|
1 Participants
|
0 Participants
|
5 Participants
|
Adverse Events
Dose Escalation Phase: Cohort 1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Dose Escalation Phase: Cohort 2
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Dose Escalation Phase: Cohort 3 and Dose Expansion Phase
Serious events: 2 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dose Escalation Phase: Cohort 1
n=4 participants at risk
Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 2
n=4 participants at risk
Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 3 and Dose Expansion Phase
n=13 participants at risk
Dose Escalation Phase: Cohort 3 consisted of patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
The Dose Expansion Phase consisted of patients treated at 100mg buparlisib once daily for a total of fourteen days after the MTD had been established at 100mg buparlisib. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory infection
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/13 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Vascular disorders
Peripheral Ischaemia
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/13 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
Other adverse events
| Measure |
Dose Escalation Phase: Cohort 1
n=4 participants at risk
Patients treated at 50mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 2
n=4 participants at risk
Patients treated at 80mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
Dose Escalation Phase: Cohort 3 and Dose Expansion Phase
n=13 participants at risk
Dose Escalation Phase: Cohort 3 consisted of patients treated at 100mg buparlisib once daily for a total of fourteen days for the dose escalation phase. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
The Dose Expansion Phase consisted of patients treated at 100mg buparlisib once daily for a total of fourteen days after the MTD had been established at 100mg buparlisib. One week after commencing buparlisib, patients started palliative radiotherapy treatment. Radiotherapy treatment was delivered as 20Gy in 5 fractions over a one week period.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
15.4%
2/13 • Number of events 3 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 2 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
30.8%
4/13 • Number of events 6 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
50.0%
2/4 • Number of events 2 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
23.1%
3/13 • Number of events 3 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
75.0%
3/4 • Number of events 3 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
100.0%
4/4 • Number of events 4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
15.4%
2/13 • Number of events 2 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
General disorders
Chest Pain
|
75.0%
3/4 • Number of events 3 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
General disorders
Fatigue
|
75.0%
3/4 • Number of events 3 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
75.0%
3/4 • Number of events 5 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
76.9%
10/13 • Number of events 13 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
23.1%
3/13 • Number of events 4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
75.0%
3/4 • Number of events 3 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
100.0%
4/4 • Number of events 5 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
30.8%
4/13 • Number of events 4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/13 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Cardiac disorders
Sinus Tachycardia
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/13 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Injury, poisoning and procedural complications
Radiotherapy Dermatitis
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/13 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Infections and infestations
Oral candidiasis
|
50.0%
2/4 • Number of events 2 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/13 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
2/4 • Number of events 2 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
23.1%
3/13 • Number of events 3 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 2 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/13 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
50.0%
2/4 • Number of events 2 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
23.1%
3/13 • Number of events 4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
25.0%
1/4 • Number of events 3 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 2 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
50.0%
2/4 • Number of events 2 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
15.4%
2/13 • Number of events 2 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/13 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
50.0%
2/4 • Number of events 2 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Peripheral ischaemia
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/13 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
50.0%
2/4 • Number of events 2 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/13 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/13 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/13 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/13 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/13 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
25.0%
1/4 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 2 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 2 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/13 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 2 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Infections and infestations
Hyperhidrosis
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Psychiatric disorders
Personality Change
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Skin and subcutaneous tissue disorders
Skin Mass
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Obstruction
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Skin and subcutaneous tissue disorders
Skin Reaction
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Eye disorders
Heterophoria
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Skin and subcutaneous tissue disorders
Fungating wound
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Eye disorders
Diplopia
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
General disorders
Pain
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
0.00%
0/4 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
7.7%
1/13 • Number of events 1 • The Investigator monitored each patient for clinical and laboratory evidence of adverse events on a routine basis throughout the study from the point of receiving any research procedures through study completion.
Participants were assessed for adverse events by site staff during their participation in the trial.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place