Trial Outcomes & Findings for CASCARA: Castration Sensitive Carboplatin, Cabazitaxel and Abiraterone (NCT NCT03934840)
NCT ID: NCT03934840
Last Updated: 2026-05-26
Results Overview
Number of patients who have no PSA or radiographic progression as determined by RECIST 1.1 or PCWG3 criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
1 Year
Results posted on
2026-05-26
Participant Flow
Participant milestones
| Measure |
Carboplatin, Cabazitaxel and Abiraterone
Cabazitaxel: 20 mg/m2 Q 21 days
Carboplatin: AUC 4 Q21 Days x 6 cycles with ADT
Abiraterone: 1000 mg PO daily
Prednisone: 5 mg PO daily on chemotherapy completion
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Carboplatin, Cabazitaxel and Abiraterone
Cabazitaxel: 20 mg/m2 Q 21 days
Carboplatin: AUC 4 Q21 Days x 6 cycles with ADT
Abiraterone: 1000 mg PO daily
Prednisone: 5 mg PO daily on chemotherapy completion
|
|---|---|
|
Overall Study
Death
|
10
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
CASCARA: Castration Sensitive Carboplatin, Cabazitaxel and Abiraterone
Baseline characteristics by cohort
| Measure |
Carboplatin, Cabazitaxel and Abiraterone
n=61 Participants
Cabazitaxel: 20 mg/m2 Q 21 days
Carboplatin: AUC 4 Q21 Days x 6 cycles with ADT
Abiraterone: 1000 mg PO daily
Prednisone: 5 mg PO daily on chemotherapy completion
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 1 YearNumber of patients who have no PSA or radiographic progression as determined by RECIST 1.1 or PCWG3 criteria
Outcome measures
| Measure |
Carboplatin, Cabazitaxel and Abiraterone
n=61 Participants
Cabazitaxel: 20 mg/m2 Q 21 days
Carboplatin: AUC 4 Q21 Days x 6 cycles with ADT
Abiraterone: 1000 mg PO daily
Prednisone: 5 mg PO daily on chemotherapy completion
|
|---|---|
|
Prostate-Specific Antigen (PSA) or Radiographic Progression
|
10 participants
Interval 7.5 to 26.8
|
SECONDARY outcome
Timeframe: 1 YearPercentage of participants achieving Progression Free Survival
Outcome measures
| Measure |
Carboplatin, Cabazitaxel and Abiraterone
n=61 Participants
Cabazitaxel: 20 mg/m2 Q 21 days
Carboplatin: AUC 4 Q21 Days x 6 cycles with ADT
Abiraterone: 1000 mg PO daily
Prednisone: 5 mg PO daily on chemotherapy completion
|
|---|---|
|
Progression-Free Survival (PFS)
|
81.1 Percentage of participants
Interval 68.5 to 89.1
|
SECONDARY outcome
Timeframe: 1 YearTime to PSA nadir
Outcome measures
| Measure |
Carboplatin, Cabazitaxel and Abiraterone
n=61 Participants
Cabazitaxel: 20 mg/m2 Q 21 days
Carboplatin: AUC 4 Q21 Days x 6 cycles with ADT
Abiraterone: 1000 mg PO daily
Prednisone: 5 mg PO daily on chemotherapy completion
|
|---|---|
|
PSA Nadir
|
176 Days
Interval 0.0 to 361.0
|
SECONDARY outcome
Timeframe: 1 YearSafety and Tolerability
Outcome measures
| Measure |
Carboplatin, Cabazitaxel and Abiraterone
n=61 Participants
Cabazitaxel: 20 mg/m2 Q 21 days
Carboplatin: AUC 4 Q21 Days x 6 cycles with ADT
Abiraterone: 1000 mg PO daily
Prednisone: 5 mg PO daily on chemotherapy completion
|
|---|---|
|
Incidence of Adverse Events
|
697 Count of events
|
SECONDARY outcome
Timeframe: 1 YearPopulation: 45 out of the 61 patients had valid test results that were able to be analyzed.
PSA complete response rate (PSA \<=0.2 ng/mL) in patient with mutations in DNA repair genes
Outcome measures
| Measure |
Carboplatin, Cabazitaxel and Abiraterone
n=45 Participants
Cabazitaxel: 20 mg/m2 Q 21 days
Carboplatin: AUC 4 Q21 Days x 6 cycles with ADT
Abiraterone: 1000 mg PO daily
Prednisone: 5 mg PO daily on chemotherapy completion
|
|---|---|
|
PSA Complete Response Rate
HRRm
|
3 Participants
|
|
PSA Complete Response Rate
TP53m
|
13 Participants
|
|
PSA Complete Response Rate
ERGm
|
10 Participants
|
|
PSA Complete Response Rate
SPOPm
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 YearPopulation: 46 out of the 61 patients had valid test results that were able to be analyzed.
PSA complete response rate (PSA \<=0.2 ng/ml) in patient without mutations in DNA repair genes
Outcome measures
| Measure |
Carboplatin, Cabazitaxel and Abiraterone
n=46 Participants
Cabazitaxel: 20 mg/m2 Q 21 days
Carboplatin: AUC 4 Q21 Days x 6 cycles with ADT
Abiraterone: 1000 mg PO daily
Prednisone: 5 mg PO daily on chemotherapy completion
|
|---|---|
|
PSA Complete Response Rate
HRRwt
|
26 Participants
|
|
PSA Complete Response Rate
TP53wt
|
16 Participants
|
|
PSA Complete Response Rate
ERGwt
|
19 Participants
|
|
PSA Complete Response Rate
SPOPwt
|
25 Participants
|
SECONDARY outcome
Timeframe: 1 YearTime to PSA progression
Outcome measures
| Measure |
Carboplatin, Cabazitaxel and Abiraterone
n=10 Participants
Cabazitaxel: 20 mg/m2 Q 21 days
Carboplatin: AUC 4 Q21 Days x 6 cycles with ADT
Abiraterone: 1000 mg PO daily
Prednisone: 5 mg PO daily on chemotherapy completion
|
|---|---|
|
PSA Progression
|
273 Days
Interval 63.0 to 361.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 46 out of the 61 patients had valid test results that were able to be analyzed.
Incidence of HRD
Outcome measures
| Measure |
Carboplatin, Cabazitaxel and Abiraterone
n=46 Participants
Cabazitaxel: 20 mg/m2 Q 21 days
Carboplatin: AUC 4 Q21 Days x 6 cycles with ADT
Abiraterone: 1000 mg PO daily
Prednisone: 5 mg PO daily on chemotherapy completion
|
|---|---|
|
Incidence of Homologous Recombination Deficiency (HRD)
|
9 Participants
|
Adverse Events
Carboplatin, Cabazitaxel and Abiraterone
Serious events: 8 serious events
Other events: 60 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Carboplatin, Cabazitaxel and Abiraterone
n=61 participants at risk
Cabazitaxel: 20 mg/m2 Q 21 days
Carboplatin: AUC 4 Q21 Days x 6 cycles with ADT
Abiraterone: 1000 mg PO daily
Prednisone: 5 mg PO daily on chemotherapy completion
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Cardiac disorders
Angina pectoris
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Anal ulcer
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
General disorders
Death
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
General disorders
Fatigue
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
General disorders
Sudden death
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Hepatitis acute
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Infections and infestations
Diverticulitis
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Infections and infestations
Osteomyelitis
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Infections and infestations
Sepsis
|
6.6%
4/61 • Number of events 4 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Nervous system disorders
Cognitive disorder
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Nervous system disorders
Seizure
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Nervous system disorders
Syncope
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Cystitis noninfective
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Haematuria
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Vascular disorders
Aortic aneurysm
|
1.6%
1/61 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Carboplatin, Cabazitaxel and Abiraterone
n=61 participants at risk
Cabazitaxel: 20 mg/m2 Q 21 days
Carboplatin: AUC 4 Q21 Days x 6 cycles with ADT
Abiraterone: 1000 mg PO daily
Prednisone: 5 mg PO daily on chemotherapy completion
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Cardiac disorders
Arrhythmia
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Cardiac disorders
Palpitations
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Ear and labyrinth disorders
Ear pain
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Vertigo
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Endocrine disorders
Hyperparathyroidism
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Eye disorders
Conjunctival haemorrhage
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Eye disorders
Papilloedema
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Eye disorders
Vision blurred
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Eye disorders
Vitreous floaters
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal distension
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Anal ulcer
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
24.6%
15/61 • Number of events 15 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
36.1%
22/61 • Number of events 24 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
9.8%
6/61 • Number of events 6 • 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Eructation
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.2%
5/61 • Number of events 5 • 1 year
|
|
Gastrointestinal disorders
Gingival swelling
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Hyperaesthesia teeth
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
50.8%
31/61 • Number of events 31 • 1 year
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Oral pain
|
4.9%
3/61 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Stomatitis
|
6.6%
4/61 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Tongue discolouration
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Tooth loss
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Toothache
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
19.7%
12/61 • Number of events 12 • 1 year
|
|
General disorders
Chills
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
General disorders
Death
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
General disorders
Fatigue
|
68.9%
42/61 • Number of events 42 • 1 year
|
|
General disorders
Gait disturbance
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
General disorders
Influenza like illness
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
General disorders
Infusion site extravasation
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
General disorders
Localised oedema
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
General disorders
Oedema peripheral
|
11.5%
7/61 • Number of events 7 • 1 year
|
|
General disorders
Pain
|
11.5%
7/61 • Number of events 7 • 1 year
|
|
General disorders
Pyrexia
|
4.9%
3/61 • Number of events 3 • 1 year
|
|
General disorders
Sudden death
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Hepatitis acute
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Infections and infestations
Coronavirus infection
|
6.6%
4/61 • Number of events 4 • 1 year
|
|
Infections and infestations
COVID-19
|
6.6%
4/61 • Number of events 4 • 1 year
|
|
Infections and infestations
Diverticulitis
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Infections and infestations
Folliculitis
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Infections and infestations
Gingivitis
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Infections and infestations
Herpes simplex reactivation
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Infections and infestations
Osteomyelitis
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Infections and infestations
Scrotal infection
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Infections and infestations
Skin infection
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Infections and infestations
Tinea pedis
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
6.6%
4/61 • Number of events 4 • 1 year
|
|
Infections and infestations
Contusion
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
9.8%
6/61 • Number of events 6 • 1 year
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.9%
3/61 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Activated partial thromboplastin time prolonged
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
8.2%
5/61 • Number of events 5 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
6.6%
4/61 • Number of events 4 • 1 year
|
|
Investigations
Blood alkaline phosphatase increased
|
13.1%
8/61 • Number of events 8 • 1 year
|
|
Investigations
Blood bicarbonate decreased
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Investigations
Blood bilirubin increased
|
4.9%
3/61 • Number of events 3 • 1 year
|
|
Investigations
Blood creatinine increased
|
11.5%
7/61 • Number of events 7 • 1 year
|
|
Investigations
Blood lactate dehydrogenase increased
|
11.5%
7/61 • Number of events 7 • 1 year
|
|
Investigations
Blood urea increased
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Investigations
Glomerular filtration rate decreased
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Investigations
International normalised ratio increased
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
8.2%
5/61 • Number of events 5 • 1 year
|
|
Investigations
Monocyte count increased
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Investigations
Neutrophil count decreased
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Investigations
Neutrophil count increased
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Investigations
Platelet count decreased
|
4.9%
3/61 • Number of events 3 • 1 year
|
|
Investigations
Protein total decreased
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Investigations
Weight increased
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Investigations
White blood cell count decreased
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Investigations
White blood cell count increased
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Investigations
Decreased appetite
|
14.8%
9/61 • Number of events 9 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
18.0%
11/61 • Number of events 11 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.9%
3/61 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.9%
3/61 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.6%
4/61 • Number of events 4 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.1%
8/61 • Number of events 8 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.9%
3/61 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Increased appetite
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Arthralgia
|
4.9%
3/61 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.8%
6/61 • Number of events 6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
14.8%
9/61 • Number of events 9 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
11.5%
7/61 • Number of events 7 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.2%
5/61 • Number of events 5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.5%
7/61 • Number of events 7 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Basal cell carcinoma
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cognitive disorder
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Nervous system disorders
Dizziness
|
16.4%
10/61 • Number of events 10 • 1 year
|
|
Nervous system disorders
Dysaesthesia
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
8.2%
5/61 • Number of events 5 • 1 year
|
|
Nervous system disorders
Headache
|
11.5%
7/61 • Number of events 7 • 1 year
|
|
Nervous system disorders
Hypoaesthesia
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Nervous system disorders
Paraesthesia
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
18.0%
11/61 • Number of events 11 • 1 year
|
|
Nervous system disorders
Syncope
|
4.9%
3/61 • Number of events 3 • 1 year
|
|
Nervous system disorders
Taste disorder
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Nervous system disorders
Acute kidney injury
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Bladder spasm
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Cystitis noninfective
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Dysuria
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Haematuria
|
9.8%
6/61 • Number of events 6 • 1 year
|
|
Renal and urinary disorders
Micturition urgency
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Nocturia
|
9.8%
6/61 • Number of events 6 • 1 year
|
|
Renal and urinary disorders
Pollakiuria
|
6.6%
4/61 • Number of events 4 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary tract pain
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Balanoposthitis
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Reproductive system and breast disorders
Penile erythema
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Testicular pain
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Cough
|
9.8%
6/61 • Number of events 6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.4%
10/61 • Number of events 10 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.2%
5/61 • Number of events 5 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
8.2%
5/61 • Number of events 5 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Actinic keratosis
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.1%
8/61 • Number of events 8 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.9%
3/61 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Vascular disorders
Aortic stenosis
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Vascular disorders
Embolism
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Vascular disorders
Flushing
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Vascular disorders
Hot flush
|
52.5%
32/61 • Number of events 32 • 1 year
|
|
Vascular disorders
Hypertension
|
8.2%
5/61 • Number of events 5 • 1 year
|
|
Vascular disorders
Hypotension
|
4.9%
3/61 • Number of events 3 • 1 year
|
|
Vascular disorders
Orthostatic hypotension
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Vascular disorders
Phlebitis
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Vascular disorders
Thrombophlebitis superficial
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Eye disorders
Erythema of eyelid
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Infections and infestations
Herpes zoster
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Vascular disorders
Aortic aneurysm
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Nervous system disorders
Seizure
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Agitation
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Anxiety
|
6.6%
4/61 • Number of events 4 • 1 year
|
|
Psychiatric disorders
Depression
|
4.9%
3/61 • Number of events 3 • 1 year
|
|
Psychiatric disorders
Insomnia
|
23.0%
14/61 • Number of events 14 • 1 year
|
|
Psychiatric disorders
Irritability
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Panic attack
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
39.3%
24/61 • Number of events 33 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Lymph node pain
|
1.6%
1/61 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.6%
1/61 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place