Trial Outcomes & Findings for AZD4547 & Anastrozole or Letrozole (NSAIs) in ER+ Breast Cancer Patients Who Have Progressed on NSAIs (RADICAL) (NCT NCT01791985)
NCT ID: NCT01791985
Last Updated: 2022-08-22
Results Overview
Safety and tolerability of AZD4547 to be used in combination with a standard dose of anastrozole or letrozole, as assessed by Dose limiting toxicity (DLT) This is the primary outcome measure in the Safety Run-In part of the study.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Dose limiting toxicity (DLT) assessment window - days 1 to 28 of cycle 1
Results posted on
2022-08-22
Participant Flow
Participant milestones
| Measure |
AZD4547
Participants received NSAI (anastrozole (1mg) or letrozole (2.5mg)), orally, once daily together with twice daily AZD4547 (80mg).
AZD4547 was given on an intermittent schedule of one week on / one week off.
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
AZD4547
Participants received NSAI (anastrozole (1mg) or letrozole (2.5mg)), orally, once daily together with twice daily AZD4547 (80mg).
AZD4547 was given on an intermittent schedule of one week on / one week off.
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
AZD4547 & Anastrozole or Letrozole (NSAIs) in ER+ Breast Cancer Patients Who Have Progressed on NSAIs (RADICAL)
Baseline characteristics by cohort
| Measure |
AZD4547
n=52 Participants
Participants received NSAI (anastrozole (1mg) or letrozole (2.5mg)), orally, once daily together with twice daily AZD4547 (80mg).
AZD4547 will be given on an intermittent schedule of one week on / one week off.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
56.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown or Not reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
52 participants
n=5 Participants
|
|
Smoking
Never
|
29 Participants
n=5 Participants
|
|
Smoking
Past
|
18 Participants
n=5 Participants
|
|
Smoking
Current
|
3 Participants
n=5 Participants
|
|
Smoking
Unknown or not reported
|
2 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Status
Fully active
|
33 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Status
Restricted in physically strenuous activity
|
19 Participants
n=5 Participants
|
|
Tumour Grade
Grade 1 or 2
|
25 Participants
n=5 Participants
|
|
Tumour Grade
Grade 3 or 4
|
14 Participants
n=5 Participants
|
|
Tumour Grade
Unknown
|
13 Participants
n=5 Participants
|
|
ECG
Normal
|
33 Participants
n=5 Participants
|
|
ECG
Abnormal
|
19 Participants
n=5 Participants
|
|
Echocardiogram (ECHO) / Multiplegated acquisition (MUGA) Scan
Normal
|
49 Participants
n=5 Participants
|
|
Echocardiogram (ECHO) / Multiplegated acquisition (MUGA) Scan
Abnormal
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Dose limiting toxicity (DLT) assessment window - days 1 to 28 of cycle 1Safety and tolerability of AZD4547 to be used in combination with a standard dose of anastrozole or letrozole, as assessed by Dose limiting toxicity (DLT) This is the primary outcome measure in the Safety Run-In part of the study.
Outcome measures
| Measure |
AZD4547
n=52 Participants
Participants received NSAI (anastrozole (1mg) or letrozole (2.5mg)), orally, once daily together with twice daily AZD4547 (80mg).
AZD4547 will be given on an intermittent schedule of one week on / one week off.
|
|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
10 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Out of 52 enrolled patients, 43 patients have analyzable data. Prior to week 12, there were 8 patients who discontinued study treatment prior to progression and 1 patient who had disease progression died before tumour measurements could be taken. Therefore a total of 9 patients cannot be included in the analysis of the primary outcome.
This is the primary outcome measure in the Randomised Phase IIa part of the study. This is the proportion of tumour size change from baseline to week 12 (or progression if prior to week 12) based on local review of results.
Outcome measures
| Measure |
AZD4547
n=43 Participants
Participants received NSAI (anastrozole (1mg) or letrozole (2.5mg)), orally, once daily together with twice daily AZD4547 (80mg).
AZD4547 will be given on an intermittent schedule of one week on / one week off.
|
|---|---|
|
Proportion of Tumour Size Change at 12 Weeks (or Progression if Prior to Week 12)
|
0.08 Proportion of tumour size change
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: 6, 20 and 28 weeksPopulation: Out of 52 enrolled patients, 48 had analyzable data at 6th week, 41 at 20th week and 40 at 28th week. At specific time points, some patients may have withdrawn or already discontinued study medication.
Proportion of tumour size change at 6, 20 and 28 weeks to assess the efficacy of AZD4547 in combination with anastrozole or letrozole. This outcome measure is based on local review.
Outcome measures
| Measure |
AZD4547
n=48 Participants
Participants received NSAI (anastrozole (1mg) or letrozole (2.5mg)), orally, once daily together with twice daily AZD4547 (80mg).
AZD4547 will be given on an intermittent schedule of one week on / one week off.
|
|---|---|
|
Proportion of Tumour Size Change at 6, 20 and 28 Weeks
Proportion of tumour size change at week 6
|
0.04 Proportion of tumuour size change
Standard Deviation 0.29
|
|
Proportion of Tumour Size Change at 6, 20 and 28 Weeks
Proportion of tumour size change at week 20
|
0.09 Proportion of tumuour size change
Standard Deviation 0.36
|
|
Proportion of Tumour Size Change at 6, 20 and 28 Weeks
Proportion of tumour size change at week 28
|
0.10 Proportion of tumuour size change
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: 6, 12, 20 and 28 weeksTumour response (RECIST criteria) at 6, 12, 20 and 28 weeks to assess the efficacy of AZD4547 in combination with anastrozole or letrozole. This outcome measure is based on local review.
Outcome measures
| Measure |
AZD4547
n=52 Participants
Participants received NSAI (anastrozole (1mg) or letrozole (2.5mg)), orally, once daily together with twice daily AZD4547 (80mg).
AZD4547 will be given on an intermittent schedule of one week on / one week off.
|
|---|---|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 20 · Complete response
|
0 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 6 · Complete response
|
0 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 6 · Partial response
|
2 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 6 · Stable disease
|
31 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 6 · Progressive disease
|
16 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 6 · Progressive disease before scan
|
1 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 6 · Withdrawn before scan
|
2 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 6 · Scan not done or not available
|
0 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 12 · Complete response
|
0 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 12 · Partial response
|
1 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 12 · Stable disease
|
18 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 12 · Progressive disease
|
8 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 12 · Progressive disease before scan
|
17 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 12 · Withdrawn before scan
|
6 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 12 · Scan not done or not available
|
2 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 20 · Partial response
|
2 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 20 · Stable disease
|
13 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 20 · Progressive disease
|
3 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 20 · Progressive disease before scan
|
26 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 20 · Withdrawn before scan
|
8 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 20 · Scan not done or not available
|
0 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 28 · Complete response
|
0 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 28 · Partial response
|
2 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 28 · Stable disease
|
10 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 28 · Progressive disease
|
1 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 28 · Progressive disease before scan
|
30 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 28 · Withdrawn before scan
|
9 Participants
|
|
Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
Overall response at week 28 · Scan not done or not available
|
0 Participants
|
SECONDARY outcome
Timeframe: 6, 12, 20 and 28 weeksObjective Response at 6, 12, 20 and 28 weeks to assess the efficacy of AZD4547 in combination with anastrozole or letrozole. The Objective Response Rate (ORR) is defined as the proportion of overall complete response (CR) and overall partial response (PR) among all patients who receive at least one dose of study treatment. This outcome measure is based on local review.
Outcome measures
| Measure |
AZD4547
n=52 Participants
Participants received NSAI (anastrozole (1mg) or letrozole (2.5mg)), orally, once daily together with twice daily AZD4547 (80mg).
AZD4547 will be given on an intermittent schedule of one week on / one week off.
|
|---|---|
|
Objective Response at 6, 12, 20 and 28 Weeks
Objective response at week 6
|
0 Participants
|
|
Objective Response at 6, 12, 20 and 28 Weeks
Objective response at week 12
|
2 Participants
|
|
Objective Response at 6, 12, 20 and 28 Weeks
Objective response at week 20
|
3 Participants
|
|
Objective Response at 6, 12, 20 and 28 Weeks
Objective response at week 28
|
3 Participants
|
SECONDARY outcome
Timeframe: 42 monthsProgression Free Survival (PFS) was defined as the time from study enrolment to first evidence of progression. Progression is defined as overall progressive disease identified at follow-up or confirmed disease progression at the end of the trial or death.
Outcome measures
| Measure |
AZD4547
n=52 Participants
Participants received NSAI (anastrozole (1mg) or letrozole (2.5mg)), orally, once daily together with twice daily AZD4547 (80mg).
AZD4547 will be given on an intermittent schedule of one week on / one week off.
|
|---|---|
|
Progression Free Survival
|
3.1 months
Interval 2.4 to 6.2
|
Adverse Events
AZD4547
Serious events: 10 serious events
Other events: 52 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
AZD4547
n=52 participants at risk
Participants received NSAI (anastrozole (1mg) or letrozole (2.5mg)), orally, once daily together with twice daily AZD4547 (80mg).
AZD4547 will be given on an intermittent schedule of one week on / one week off.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Fractured femur
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Injury, poisoning and procedural complications
Fractured bone
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Infections and infestations
Infections and Infestations - Other
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Infections and infestations
sepsis
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Renal and urinary disorders
UTI
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Psychiatric disorders
depression
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Nervous system disorders
Unsteadiness on feet
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Surgical and medical procedures
Surgical or medical procedure - prolongation of hospital stay
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
Other adverse events
| Measure |
AZD4547
n=52 participants at risk
Participants received NSAI (anastrozole (1mg) or letrozole (2.5mg)), orally, once daily together with twice daily AZD4547 (80mg).
AZD4547 will be given on an intermittent schedule of one week on / one week off.
|
|---|---|
|
Reproductive system and breast disorders
Breast atrophy
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Reproductive system and breast disorders
Breast discomfort
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Reproductive system and breast disorders
Breast inflammation
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Reproductive system and breast disorders
Genital discharge
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.3%
9/52 • Number of events 10 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Blood and lymphatic system disorders
Anaemia
|
13.5%
7/52 • Number of events 9 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.9%
1/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Blood and lymphatic system disorders
Metastases to lymph nodes
|
1.9%
1/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.8%
2/52 • Number of events 5 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.5%
6/52 • Number of events 7 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Cardiac disorders
Bradycardia
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Cardiac disorders
Cardiac aneurysm
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Cardiac disorders
Left ventricular dysfunction
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Cardiac disorders
Mitral valve incompetence
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Cardiac disorders
Palpitations
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Cardiac disorders
Tachycardia
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Cardiac disorders
Ventricular hypokinesia
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Ear and labyrinth disorders
Ear infection
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Age-related macular degeneration
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Cataract
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Conjunctival hyperaemia
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
4/52 • Number of events 5 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Conjunctivitis
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Corneal erosion multiple
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Corneal oedema
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Detachment of macular retinal pigment epithelium
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
17.3%
9/52 • Number of events 14 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Dry eye
|
17.3%
9/52 • Number of events 10 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Eye disorder
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Eye pruritus
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Growth of eyelashes
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Increased intraocular pressure
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Iritis
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Keratitis
|
3.8%
2/52 • Number of events 4 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Lacrimation increased
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Macular degeneration
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Maculopathy
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Ocular hyperaemia
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Papilloedema
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Relative afferent pupillary defect
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Retinal detachment
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Retinal pigment epitheliopathy
|
7.7%
4/52 • Number of events 6 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Ulcerative keratitis
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Vision blurred
|
5.8%
3/52 • Number of events 3 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Eye disorders
Visual impairment
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Abdominal distension
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
4/52 • Number of events 7 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Constipation
|
38.5%
20/52 • Number of events 23 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Diarrhoea
|
30.8%
16/52 • Number of events 30 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Dry mouth
|
44.2%
23/52 • Number of events 30 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Dyspepsia
|
23.1%
12/52 • Number of events 17 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.8%
3/52 • Number of events 3 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Glossodynia
|
9.6%
5/52 • Number of events 5 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Hypogeusia
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Lip dry
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
11.5%
6/52 • Number of events 14 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Nausea
|
40.4%
21/52 • Number of events 26 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Oesophagitis
|
3.8%
2/52 • Number of events 4 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Oral pain
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Stomatitis
|
15.4%
8/52 • Number of events 11 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Tongue coated
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Tongue eruption
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Tongue ulceration
|
7.7%
4/52 • Number of events 6 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Toothache
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
8/52 • Number of events 10 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
General disorders
Chest discomfort
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
General disorders
Chest pain
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
General disorders
Fatigue
|
23.1%
12/52 • Number of events 20 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
General disorders
Influenza like illness
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
General disorders
Lethargy
|
13.5%
7/52 • Number of events 9 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
General disorders
Mucosal inflammation
|
11.5%
6/52 • Number of events 6 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
General disorders
Oedema peripheral
|
5.8%
3/52 • Number of events 3 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
General disorders
Wound secretion
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discharge discolouration
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Immune system disorders
Seasonal allergy
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Infections and infestations
Influenza
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Infections and infestations
Laryngitis
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Infections and infestations
Lung infection
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Infections and infestations
Neutropenic sepsis
|
1.9%
1/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Infections and infestations
Oral candidiasis
|
9.6%
5/52 • Number of events 6 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Infections and infestations
Oral herpes
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Infections and infestations
Pneumonia
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Infections and infestations
Viral pharyngitis
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Infections and infestations
Vulvovaginal candidiasis
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Infections and infestations
Wound infection
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Injury, poisoning and procedural complications
Contusion
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.5%
6/52 • Number of events 6 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Injury, poisoning and procedural complications
Face injury
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Injury, poisoning and procedural complications
Fall
|
5.8%
3/52 • Number of events 3 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Alanine aminotransferase increased
|
17.3%
9/52 • Number of events 15 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Aspartate aminotransferase increased
|
17.3%
9/52 • Number of events 16 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Blood albumin decreased
|
9.6%
5/52 • Number of events 13 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Blood alkaline phosphatase increased
|
15.4%
8/52 • Number of events 12 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Blood bilirubin increased
|
3.8%
2/52 • Number of events 4 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Blood calcium decreased
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Blood calcium increased
|
13.5%
7/52 • Number of events 9 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Blood cholesterol increased
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Blood creatinine increased
|
1.9%
1/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Blood glucose increased
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Blood magnesium decreased
|
9.6%
5/52 • Number of events 5 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Blood magnesium increased
|
1.9%
1/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Blood phosphorus decreased
|
9.6%
5/52 • Number of events 7 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Blood phosphorus increased
|
32.7%
17/52 • Number of events 30 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Blood potassium decreased
|
1.9%
1/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Blood pressure increased
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Blood urine present
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Calcium phosphate product increased
|
13.5%
7/52 • Number of events 11 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Carbohydrate antigen 15-3 increased
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Dermatologic examination abnormal
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Ejection fraction decreased
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Haemoglobin decreased
|
1.9%
1/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Neutrophil count decreased
|
1.9%
1/52 • Number of events 5 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Platelet count increased
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Protein urine present
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.9%
1/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Weight decreased
|
9.6%
5/52 • Number of events 6 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
Weight increased
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
White blood cell count decreased
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Investigations
White blood cells urine
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Metabolism and nutrition disorders
Aphagia
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.2%
10/52 • Number of events 17 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.8%
3/52 • Number of events 4 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
19.2%
10/52 • Number of events 14 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.9%
1/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.2%
11/52 • Number of events 13 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.6%
5/52 • Number of events 6 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Musculoskeletal and connective tissue disorders
Femur fracture
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Musculoskeletal and connective tissue disorders
Fibroma
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Musculoskeletal and connective tissue disorders
Foot fracture
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Musculoskeletal and connective tissue disorders
Ligament sprain
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.8%
2/52 • Number of events 5 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.8%
3/52 • Number of events 4 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.8%
2/52 • Number of events 3 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
4/52 • Number of events 4 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to eye
|
1.9%
1/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Nervous system disorders
Ageusia
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Nervous system disorders
Balance disorder
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Nervous system disorders
Convulsion
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Renal and urinary disorders
Urinary tract infection
|
17.3%
9/52 • Number of events 15 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Nervous system disorders
Dizziness
|
7.7%
4/52 • Number of events 4 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Nervous system disorders
Dysgeusia
|
28.8%
15/52 • Number of events 17 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Nervous system disorders
Headache
|
9.6%
5/52 • Number of events 5 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Nervous system disorders
Hypoaesthesia oral
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Nervous system disorders
Neurotoxicity
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Nervous system disorders
Paraesthesia
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Nervous system disorders
Somnolence
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Psychiatric disorders
Depressed mood
|
5.8%
3/52 • Number of events 5 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Psychiatric disorders
Depression
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Psychiatric disorders
Panic attack
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Renal and urinary disorders
Haematuria
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Viral upper respiratory tract infection
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
38.5%
20/52 • Number of events 25 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Contusion
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.4%
8/52 • Number of events 9 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Flushing
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.8%
2/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Laceration
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
7.7%
4/52 • Number of events 5 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
15.4%
8/52 • Number of events 8 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Nail infection
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
11.5%
6/52 • Number of events 6 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
5.8%
3/52 • Number of events 4 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
1.9%
1/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Paronychia
|
5.8%
3/52 • Number of events 4 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.9%
1/52 • Number of events 2 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Social circumstances
Corrective lens user
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Surgical and medical procedures
Breast operation
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Surgical and medical procedures
Tooth extraction
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Vascular disorders
Embolism
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Vascular disorders
Epistaxis
|
17.3%
9/52 • Number of events 12 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Vascular disorders
Eye contusion
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Vascular disorders
Hypertension
|
5.8%
3/52 • Number of events 4 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
|
Vascular disorders
Hypotension
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) were collected throughout the study, from the point that the RADICAL team confirmed patient eligibility until the end of patient follow-up, 42 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place