Trial Outcomes & Findings for Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer (NCT NCT01949337)
NCT ID: NCT01949337
Last Updated: 2023-09-28
Results Overview
Overall survival is defined as the time from study registration to death due to any cause.
Recruitment status
UNKNOWN
Study phase
PHASE3
Target enrollment
1311 participants
Primary outcome timeframe
Up to 5 years post treatment
Results posted on
2023-09-28
Participant Flow
Participant milestones
| Measure |
Arm A: (Enzalutamide)
Patients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity.
|
Arm B: (Enzalutamide, Abiraterone, Prednisone)
Patients receive enzalutamide 160 mg PO QD, abiraterone 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
657
|
654
|
|
Overall Study
COMPLETED
|
657
|
654
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A: (Enzalutamide)
n=657 Participants
Patients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity.
|
Arm B: (Enzalutamide, Abiraterone, Prednisone)
n=654 Participants
Patients receive enzalutamide 160 mg PO QD, abiraterone 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity.
|
Total
n=1311 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age categories · < 60 years
|
53 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Age, Customized
Age categories · 60-69 years
|
198 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
391 Participants
n=5 Participants
|
|
Age, Customized
Age categories · 70-79 years
|
238 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
464 Participants
n=5 Participants
|
|
Age, Customized
Age categories · 80+ years
|
168 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
337 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
657 Participants
n=5 Participants
|
654 Participants
n=7 Participants
|
1311 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
84 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
543 Participants
n=5 Participants
|
545 Participants
n=7 Participants
|
1088 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
ECOG Performance Status
0
|
376 Participants
n=5 Participants
|
387 Participants
n=7 Participants
|
763 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
280 Participants
n=5 Participants
|
267 Participants
n=7 Participants
|
547 Participants
n=5 Participants
|
|
ECOG Performance Status
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 years post treatmentOverall survival is defined as the time from study registration to death due to any cause.
Outcome measures
| Measure |
Arm A: (Enzalutamide)
n=657 Participants
Patients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity.
|
Arm B: (Enzalutamide, Abiraterone, Prednisone)
n=654 Participants
Patients receive enzalutamide 160 mg PO QD, abiraterone 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS)
|
32.5 months
Interval 30.4 to 35.4
|
34.2 months
Interval 31.8 to 37.5
|
SECONDARY outcome
Timeframe: Up to 5 years post treatmentThe number of participants who has experienced at least one toxicity (defined as a grade 3 or higher adverse event deemed at least possibly related to treatment)
Outcome measures
| Measure |
Arm A: (Enzalutamide)
n=657 Participants
Patients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity.
|
Arm B: (Enzalutamide, Abiraterone, Prednisone)
n=654 Participants
Patients receive enzalutamide 160 mg PO QD, abiraterone 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants Who Has Experienced at Least One Toxicity (Defined as a Grade 3 or Higher Adverse Event Deemed at Least Possibly Related to Treatment)
|
167 Participants
|
287 Participants
|
SECONDARY outcome
Timeframe: Up to 5 years post treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 years post treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 years post treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 years post treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 years post treatmentOutcome measures
Outcome data not reported
Adverse Events
Arm A: (Enzalutamide)
Serious events: 232 serious events
Other events: 645 other events
Deaths: 372 deaths
Arm B: (Enzalutamide, Abiraterone, Prednisone)
Serious events: 269 serious events
Other events: 627 other events
Deaths: 339 deaths
Serious adverse events
| Measure |
Arm A: (Enzalutamide)
n=657 participants at risk
Patients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity.
|
Arm B: (Enzalutamide, Abiraterone, Prednisone)
n=654 participants at risk
Patients receive enzalutamide 160 mg PO QD, abiraterone 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.7%
11/657 • Number of events 12 • Up to 5 years post treatment
|
1.2%
8/654 • Number of events 10 • Up to 5 years post treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Cardiac disorders
Acute coronary syndrome
|
0.61%
4/657 • Number of events 4 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Cardiac disorders
Aortic valve disease
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Cardiac disorders
Atrial fibrillation
|
0.46%
3/657 • Number of events 3 • Up to 5 years post treatment
|
1.8%
12/654 • Number of events 14 • Up to 5 years post treatment
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Cardiac disorders
Cardiac arrest
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
1.2%
8/657 • Number of events 8 • Up to 5 years post treatment
|
1.1%
7/654 • Number of events 10 • Up to 5 years post treatment
|
|
Cardiac disorders
Chest pain - cardiac
|
1.1%
7/657 • Number of events 9 • Up to 5 years post treatment
|
1.1%
7/654 • Number of events 10 • Up to 5 years post treatment
|
|
Cardiac disorders
Heart failure
|
0.46%
3/657 • Number of events 4 • Up to 5 years post treatment
|
0.92%
6/654 • Number of events 8 • Up to 5 years post treatment
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
7/657 • Number of events 7 • Up to 5 years post treatment
|
0.92%
6/654 • Number of events 6 • Up to 5 years post treatment
|
|
Cardiac disorders
Sinus bradycardia
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Cardiac disorders
Sinus tachycardia
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Cardiac disorders
Ventricular tachycardia
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Ear and labyrinth disorders
Vertigo
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 3 • Up to 5 years post treatment
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Eye disorders
Cataract
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Eye disorders
Optic nerve disorder
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Eye disorders
Retinal detachment
|
0.15%
1/657 • Number of events 11 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Eye disorders
Retinopathy
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
7/657 • Number of events 7 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 7 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 2 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.15%
1/657 • Number of events 2 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 3 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Constipation
|
1.1%
7/657 • Number of events 9 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Diarrhea
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 5 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
0.61%
4/657 • Number of events 6 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Dysphagia
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/657 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 3 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
0.00%
0/657 • Up to 5 years post treatment
|
0.61%
4/654 • Number of events 5 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Ileus
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.46%
3/657 • Number of events 3 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Nausea
|
1.5%
10/657 • Number of events 11 • Up to 5 years post treatment
|
1.5%
10/654 • Number of events 11 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 3 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.61%
4/657 • Number of events 4 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 4 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Visceral arterial ischemia
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.91%
6/657 • Number of events 8 • Up to 5 years post treatment
|
1.1%
7/654 • Number of events 7 • Up to 5 years post treatment
|
|
General disorders
Chills
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 3 • Up to 5 years post treatment
|
|
General disorders
Death NOS
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 5 • Up to 5 years post treatment
|
|
General disorders
Edema limbs
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
General disorders
Fatigue
|
3.7%
24/657 • Number of events 32 • Up to 5 years post treatment
|
4.3%
28/654 • Number of events 34 • Up to 5 years post treatment
|
|
General disorders
Fever
|
0.46%
3/657 • Number of events 3 • Up to 5 years post treatment
|
1.2%
8/654 • Number of events 8 • Up to 5 years post treatment
|
|
General disorders
Flu like symptoms
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
General disorders
Gait disturbance
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.61%
4/654 • Number of events 4 • Up to 5 years post treatment
|
|
General disorders
Localized edema
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
General disorders
Multi-organ failure
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
General disorders
Non-cardiac chest pain
|
0.46%
3/657 • Number of events 3 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 6 • Up to 5 years post treatment
|
|
General disorders
Pain
|
0.46%
3/657 • Number of events 3 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
General disorders
Sudden death NOS
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 2 • Up to 5 years post treatment
|
|
Infections and infestations
Appendicitis
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Infections and infestations
Bladder infection
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Infections and infestations
Bone infection
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 3 • Up to 5 years post treatment
|
|
Infections and infestations
Bronchial infection
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.61%
4/657 • Number of events 6 • Up to 5 years post treatment
|
1.1%
7/654 • Number of events 8 • Up to 5 years post treatment
|
|
Infections and infestations
Joint infection
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Infections and infestations
Lung infection
|
0.61%
4/657 • Number of events 4 • Up to 5 years post treatment
|
1.7%
11/654 • Number of events 11 • Up to 5 years post treatment
|
|
Infections and infestations
Sepsis
|
0.91%
6/657 • Number of events 6 • Up to 5 years post treatment
|
2.4%
16/654 • Number of events 23 • Up to 5 years post treatment
|
|
Infections and infestations
Sinusitis
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Infections and infestations
Skin infection
|
0.00%
0/657 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 3 • Up to 5 years post treatment
|
|
Infections and infestations
Tooth infection
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Infections and infestations
Upper respiratory infection
|
0.15%
1/657 • Number of events 6 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Infections and infestations
Urinary tract infection
|
1.4%
9/657 • Number of events 11 • Up to 5 years post treatment
|
4.0%
26/654 • Number of events 37 • Up to 5 years post treatment
|
|
Infections and infestations
Wound infection
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Bruising
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Burn
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
16/657 • Number of events 18 • Up to 5 years post treatment
|
1.8%
12/654 • Number of events 14 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Fracture
|
0.76%
5/657 • Number of events 6 • Up to 5 years post treatment
|
1.4%
9/654 • Number of events 10 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.91%
6/657 • Number of events 8 • Up to 5 years post treatment
|
0.92%
6/654 • Number of events 7 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
0.76%
5/657 • Number of events 6 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Investigations
Alanine aminotransferase increased
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
2.9%
19/654 • Number of events 29 • Up to 5 years post treatment
|
|
Investigations
Alkaline phosphatase increased
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Investigations
Aspartate aminotransferase increased
|
0.46%
3/657 • Number of events 3 • Up to 5 years post treatment
|
2.1%
14/654 • Number of events 20 • Up to 5 years post treatment
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/657 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 3 • Up to 5 years post treatment
|
|
Investigations
CPK increased
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Investigations
Creatinine increased
|
0.46%
3/657 • Number of events 3 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 4 • Up to 5 years post treatment
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Investigations
INR increased
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Investigations
Investigations - Other, specify
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 3 • Up to 5 years post treatment
|
|
Investigations
Lipase increased
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 3 • Up to 5 years post treatment
|
|
Investigations
Lymphocyte count decreased
|
0.91%
6/657 • Number of events 6 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 4 • Up to 5 years post treatment
|
|
Investigations
Neutrophil count decreased
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Investigations
Platelet count decreased
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Investigations
Weight gain
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 3 • Up to 5 years post treatment
|
|
Investigations
Weight loss
|
0.76%
5/657 • Number of events 7 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Investigations
White blood cell decreased
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Acidosis
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
0.61%
4/657 • Number of events 5 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 3 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
7/657 • Number of events 8 • Up to 5 years post treatment
|
1.8%
12/654 • Number of events 13 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.2%
8/657 • Number of events 8 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 5 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.61%
4/657 • Number of events 4 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 2 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/657 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 4 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
2.0%
13/654 • Number of events 14 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.1%
7/657 • Number of events 7 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 6 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.15%
1/657 • Number of events 2 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.30%
2/657 • Number of events 3 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
10/657 • Number of events 10 • Up to 5 years post treatment
|
0.92%
6/654 • Number of events 13 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.0%
13/657 • Number of events 15 • Up to 5 years post treatment
|
1.2%
8/654 • Number of events 10 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.1%
7/657 • Number of events 8 • Up to 5 years post treatment
|
2.8%
18/654 • Number of events 22 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
1.4%
9/654 • Number of events 12 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
0.76%
5/657 • Number of events 5 • Up to 5 years post treatment
|
1.1%
7/654 • Number of events 7 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.30%
2/657 • Number of events 5 • Up to 5 years post treatment
|
0.61%
4/654 • Number of events 4 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.46%
3/657 • Number of events 3 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
2.4%
16/657 • Number of events 19 • Up to 5 years post treatment
|
4.1%
27/654 • Number of events 38 • Up to 5 years post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Nervous system disorders
Amnesia
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Nervous system disorders
Aphonia
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Nervous system disorders
Cognitive disturbance
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Nervous system disorders
Dizziness
|
0.91%
6/657 • Number of events 6 • Up to 5 years post treatment
|
1.2%
8/654 • Number of events 10 • Up to 5 years post treatment
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 2 • Up to 5 years post treatment
|
|
Nervous system disorders
Dysgeusia
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Nervous system disorders
Encephalopathy
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 4 • Up to 5 years post treatment
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Nervous system disorders
Headache
|
0.46%
3/657 • Number of events 7 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 6 • Up to 5 years post treatment
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Nervous system disorders
Memory impairment
|
0.46%
3/657 • Number of events 3 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 3 • Up to 5 years post treatment
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.46%
3/657 • Number of events 3 • Up to 5 years post treatment
|
0.61%
4/654 • Number of events 4 • Up to 5 years post treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.61%
4/657 • Number of events 4 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Nervous system disorders
Presyncope
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Nervous system disorders
Seizure
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 3 • Up to 5 years post treatment
|
|
Nervous system disorders
Stroke
|
1.4%
9/657 • Number of events 10 • Up to 5 years post treatment
|
1.2%
8/654 • Number of events 9 • Up to 5 years post treatment
|
|
Nervous system disorders
Syncope
|
1.1%
7/657 • Number of events 7 • Up to 5 years post treatment
|
0.92%
6/654 • Number of events 6 • Up to 5 years post treatment
|
|
Nervous system disorders
Transient ischemic attacks
|
0.15%
1/657 • Number of events 2 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Nervous system disorders
Tremor
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 2 • Up to 5 years post treatment
|
|
Psychiatric disorders
Anxiety
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Psychiatric disorders
Confusion
|
0.76%
5/657 • Number of events 5 • Up to 5 years post treatment
|
1.2%
8/654 • Number of events 9 • Up to 5 years post treatment
|
|
Psychiatric disorders
Delirium
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Psychiatric disorders
Depression
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 3 • Up to 5 years post treatment
|
|
Psychiatric disorders
Insomnia
|
0.61%
4/657 • Number of events 7 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Psychiatric disorders
Suicidal ideation
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
0.61%
4/657 • Number of events 4 • Up to 5 years post treatment
|
1.5%
10/654 • Number of events 11 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Bladder perforation
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 4 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Hematuria
|
1.5%
10/657 • Number of events 10 • Up to 5 years post treatment
|
1.5%
10/654 • Number of events 10 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
0.76%
5/657 • Number of events 5 • Up to 5 years post treatment
|
0.61%
4/654 • Number of events 4 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Urinary frequency
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Urinary retention
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.61%
4/654 • Number of events 5 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.76%
5/657 • Number of events 5 • Up to 5 years post treatment
|
0.92%
6/654 • Number of events 6 • Up to 5 years post treatment
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Reproductive system and breast disorders
Genital edema
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.15%
1/657 • Number of events 4 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 3 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.3%
15/657 • Number of events 19 • Up to 5 years post treatment
|
2.3%
15/654 • Number of events 17 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/657 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 4 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.61%
4/654 • Number of events 5 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
0.30%
2/657 • Number of events 3 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Social circumstances
Social circumstances - Other, specify
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
1.1%
7/657 • Number of events 14 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Vascular disorders
Hematoma
|
0.15%
1/657 • Number of events 3 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Vascular disorders
Hot flashes
|
1.7%
11/657 • Number of events 18 • Up to 5 years post treatment
|
1.2%
8/654 • Number of events 10 • Up to 5 years post treatment
|
|
Vascular disorders
Hypertension
|
4.0%
26/657 • Number of events 39 • Up to 5 years post treatment
|
4.7%
31/654 • Number of events 44 • Up to 5 years post treatment
|
|
Vascular disorders
Hypotension
|
0.46%
3/657 • Number of events 3 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 5 • Up to 5 years post treatment
|
|
Vascular disorders
Peripheral ischemia
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Vascular disorders
Thromboembolic event
|
1.5%
10/657 • Number of events 13 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 3 • Up to 5 years post treatment
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
Other adverse events
| Measure |
Arm A: (Enzalutamide)
n=657 participants at risk
Patients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity.
|
Arm B: (Enzalutamide, Abiraterone, Prednisone)
n=654 participants at risk
Patients receive enzalutamide 160 mg PO QD, abiraterone 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
28.6%
188/657 • Number of events 1185 • Up to 5 years post treatment
|
26.0%
170/654 • Number of events 1064 • Up to 5 years post treatment
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
0.76%
5/657 • Number of events 10 • Up to 5 years post treatment
|
1.4%
9/654 • Number of events 38 • Up to 5 years post treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.15%
1/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.15%
1/657 • Number of events 2 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 2 • Up to 5 years post treatment
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 7 • Up to 5 years post treatment
|
|
Cardiac disorders
Atrial fibrillation
|
0.76%
5/657 • Number of events 33 • Up to 5 years post treatment
|
1.1%
7/654 • Number of events 21 • Up to 5 years post treatment
|
|
Cardiac disorders
Atrial flutter
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.46%
3/657 • Number of events 6 • Up to 5 years post treatment
|
1.1%
7/654 • Number of events 20 • Up to 5 years post treatment
|
|
Cardiac disorders
Chest pain - cardiac
|
0.61%
4/657 • Number of events 5 • Up to 5 years post treatment
|
1.2%
8/654 • Number of events 9 • Up to 5 years post treatment
|
|
Cardiac disorders
Heart failure
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 3 • Up to 5 years post treatment
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Cardiac disorders
Palpitations
|
0.91%
6/657 • Number of events 10 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 14 • Up to 5 years post treatment
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Cardiac disorders
Pericardial effusion
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Cardiac disorders
Sinus bradycardia
|
0.91%
6/657 • Number of events 21 • Up to 5 years post treatment
|
1.4%
9/654 • Number of events 40 • Up to 5 years post treatment
|
|
Cardiac disorders
Sinus tachycardia
|
0.61%
4/657 • Number of events 5 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 15 • Up to 5 years post treatment
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.15%
1/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Cardiac disorders
Ventricular tachycardia
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Congenital, familial and genetic disorders
Congen, family, genetic disord -Oth spec
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Oth spec
|
0.15%
1/657 • Number of events 2 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Ear and labyrinth disorders
Ear pain
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 5 • Up to 5 years post treatment
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.91%
6/657 • Number of events 26 • Up to 5 years post treatment
|
0.92%
6/654 • Number of events 23 • Up to 5 years post treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
1.4%
9/657 • Number of events 33 • Up to 5 years post treatment
|
1.5%
10/654 • Number of events 32 • Up to 5 years post treatment
|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
7/657 • Number of events 43 • Up to 5 years post treatment
|
1.1%
7/654 • Number of events 27 • Up to 5 years post treatment
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 6 • Up to 5 years post treatment
|
|
Endocrine disorders
Hyperthyroidism
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Endocrine disorders
Hypothyroidism
|
0.46%
3/657 • Number of events 20 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Eye disorders
Blurred vision
|
2.3%
15/657 • Number of events 76 • Up to 5 years post treatment
|
2.8%
18/654 • Number of events 38 • Up to 5 years post treatment
|
|
Eye disorders
Cataract
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.61%
4/654 • Number of events 15 • Up to 5 years post treatment
|
|
Eye disorders
Dry eye
|
0.46%
3/657 • Number of events 7 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 15 • Up to 5 years post treatment
|
|
Eye disorders
Eye disorders - Other, specify
|
1.5%
10/657 • Number of events 23 • Up to 5 years post treatment
|
1.5%
10/654 • Number of events 40 • Up to 5 years post treatment
|
|
Eye disorders
Eye pain
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Eye disorders
Floaters
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 3 • Up to 5 years post treatment
|
|
Eye disorders
Glaucoma
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Eye disorders
Retinal detachment
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 3 • Up to 5 years post treatment
|
|
Eye disorders
Watering eyes
|
0.46%
3/657 • Number of events 19 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 26 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
0.76%
5/657 • Number of events 13 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
28/657 • Number of events 88 • Up to 5 years post treatment
|
3.4%
22/654 • Number of events 76 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Bloating
|
1.2%
8/657 • Number of events 14 • Up to 5 years post treatment
|
0.92%
6/654 • Number of events 31 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Colitis
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Colonic fistula
|
0.15%
1/657 • Number of events 10 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Constipation
|
37.3%
245/657 • Number of events 1509 • Up to 5 years post treatment
|
33.0%
216/654 • Number of events 1315 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Dental caries
|
0.15%
1/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Diarrhea
|
30.6%
201/657 • Number of events 1016 • Up to 5 years post treatment
|
26.3%
172/654 • Number of events 530 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
13/657 • Number of events 91 • Up to 5 years post treatment
|
1.7%
11/654 • Number of events 58 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
19.6%
129/657 • Number of events 682 • Up to 5 years post treatment
|
20.2%
132/654 • Number of events 678 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Dysphagia
|
1.4%
9/657 • Number of events 30 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 6 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Esophageal obstruction
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Esophagitis
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 4 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
12/657 • Number of events 129 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 4 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Gastritis
|
0.30%
2/657 • Number of events 4 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
1.5%
10/657 • Number of events 44 • Up to 5 years post treatment
|
1.8%
12/654 • Number of events 38 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
1.8%
12/657 • Number of events 20 • Up to 5 years post treatment
|
2.0%
13/654 • Number of events 47 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 5 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.61%
4/657 • Number of events 32 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 8 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
0.46%
3/657 • Number of events 3 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 5 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Nausea
|
14.6%
96/657 • Number of events 288 • Up to 5 years post treatment
|
18.3%
120/654 • Number of events 384 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.30%
2/657 • Number of events 4 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Oral pain
|
0.15%
1/657 • Number of events 2 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.30%
2/657 • Number of events 10 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 3 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Stomach pain
|
0.91%
6/657 • Number of events 14 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 3 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Tooth development disorder
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Tooth discoloration
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 15 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Toothache
|
0.30%
2/657 • Number of events 5 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Gastrointestinal disorders
Vomiting
|
13.2%
87/657 • Number of events 165 • Up to 5 years post treatment
|
12.2%
80/654 • Number of events 133 • Up to 5 years post treatment
|
|
General disorders
Chills
|
0.91%
6/657 • Number of events 6 • Up to 5 years post treatment
|
1.1%
7/654 • Number of events 11 • Up to 5 years post treatment
|
|
General disorders
Edema face
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 36 • Up to 5 years post treatment
|
|
General disorders
Edema limbs
|
26.3%
173/657 • Number of events 1354 • Up to 5 years post treatment
|
30.0%
196/654 • Number of events 1407 • Up to 5 years post treatment
|
|
General disorders
Facial pain
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 5 • Up to 5 years post treatment
|
|
General disorders
Fatigue
|
84.6%
556/657 • Number of events 7352 • Up to 5 years post treatment
|
80.4%
526/654 • Number of events 6588 • Up to 5 years post treatment
|
|
General disorders
Fever
|
0.76%
5/657 • Number of events 7 • Up to 5 years post treatment
|
0.92%
6/654 • Number of events 7 • Up to 5 years post treatment
|
|
General disorders
Flu like symptoms
|
1.8%
12/657 • Number of events 15 • Up to 5 years post treatment
|
1.2%
8/654 • Number of events 11 • Up to 5 years post treatment
|
|
General disorders
Gait disturbance
|
1.4%
9/657 • Number of events 63 • Up to 5 years post treatment
|
1.5%
10/654 • Number of events 32 • Up to 5 years post treatment
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
2.1%
14/657 • Number of events 26 • Up to 5 years post treatment
|
2.4%
16/654 • Number of events 20 • Up to 5 years post treatment
|
|
General disorders
Injection site reaction
|
0.15%
1/657 • Number of events 2 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
General disorders
Localized edema
|
0.76%
5/657 • Number of events 23 • Up to 5 years post treatment
|
0.92%
6/654 • Number of events 13 • Up to 5 years post treatment
|
|
General disorders
Malaise
|
0.91%
6/657 • Number of events 26 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 7 • Up to 5 years post treatment
|
|
General disorders
Neck edema
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
General disorders
Non-cardiac chest pain
|
2.0%
13/657 • Number of events 23 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 6 • Up to 5 years post treatment
|
|
General disorders
Pain
|
6.7%
44/657 • Number of events 150 • Up to 5 years post treatment
|
6.6%
43/654 • Number of events 199 • Up to 5 years post treatment
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Hepatobiliary disorders
Hepatic failure
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.61%
4/654 • Number of events 4 • Up to 5 years post treatment
|
|
Immune system disorders
Allergic reaction
|
0.30%
2/657 • Number of events 3 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 4 • Up to 5 years post treatment
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Infections and infestations
Bladder infection
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.61%
4/654 • Number of events 9 • Up to 5 years post treatment
|
|
Infections and infestations
Bronchial infection
|
0.76%
5/657 • Number of events 5 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Infections and infestations
Conjunctivitis
|
0.76%
5/657 • Number of events 13 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Infections and infestations
Eye infection
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Infections and infestations
Gum infection
|
0.46%
3/657 • Number of events 3 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Infections and infestations
Infections and infestations - Oth spec
|
1.7%
11/657 • Number of events 18 • Up to 5 years post treatment
|
3.1%
20/654 • Number of events 23 • Up to 5 years post treatment
|
|
Infections and infestations
Joint infection
|
0.15%
1/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Infections and infestations
Kidney infection
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 2 • Up to 5 years post treatment
|
|
Infections and infestations
Laryngitis
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Infections and infestations
Lip infection
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 2 • Up to 5 years post treatment
|
|
Infections and infestations
Lung infection
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Infections and infestations
Mucosal infection
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.61%
4/654 • Number of events 8 • Up to 5 years post treatment
|
|
Infections and infestations
Nail infection
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Infections and infestations
Otitis media
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 3 • Up to 5 years post treatment
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 5 • Up to 5 years post treatment
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Infections and infestations
Scrotal infection
|
0.15%
1/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Infections and infestations
Sepsis
|
0.00%
0/657 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 3 • Up to 5 years post treatment
|
|
Infections and infestations
Sinusitis
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.61%
4/654 • Number of events 6 • Up to 5 years post treatment
|
|
Infections and infestations
Skin infection
|
1.1%
7/657 • Number of events 9 • Up to 5 years post treatment
|
1.5%
10/654 • Number of events 14 • Up to 5 years post treatment
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Infections and infestations
Tooth infection
|
0.46%
3/657 • Number of events 3 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Infections and infestations
Upper respiratory infection
|
2.7%
18/657 • Number of events 23 • Up to 5 years post treatment
|
2.0%
13/654 • Number of events 15 • Up to 5 years post treatment
|
|
Infections and infestations
Urinary tract infection
|
2.4%
16/657 • Number of events 20 • Up to 5 years post treatment
|
3.4%
22/654 • Number of events 37 • Up to 5 years post treatment
|
|
Infections and infestations
Wound infection
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Bruising
|
1.8%
12/657 • Number of events 38 • Up to 5 years post treatment
|
4.6%
30/654 • Number of events 137 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Fall
|
4.7%
31/657 • Number of events 43 • Up to 5 years post treatment
|
5.8%
38/654 • Number of events 66 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Fracture
|
0.91%
6/657 • Number of events 21 • Up to 5 years post treatment
|
1.4%
9/654 • Number of events 37 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.30%
2/657 • Number of events 3 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
0.76%
5/657 • Number of events 10 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 5 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Intraoperative head and neck injury
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.92%
6/654 • Number of events 18 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Urostomy obstruction
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.15%
1/657 • Number of events 4 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 8 • Up to 5 years post treatment
|
|
Investigations
Alanine aminotransferase increased
|
6.1%
40/657 • Number of events 99 • Up to 5 years post treatment
|
32.9%
215/654 • Number of events 703 • Up to 5 years post treatment
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
66/657 • Number of events 210 • Up to 5 years post treatment
|
13.5%
88/654 • Number of events 281 • Up to 5 years post treatment
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
73/657 • Number of events 232 • Up to 5 years post treatment
|
33.2%
217/654 • Number of events 729 • Up to 5 years post treatment
|
|
Investigations
Blood antidiuretic hormone abnormal
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Investigations
Blood bilirubin increased
|
6.7%
44/657 • Number of events 154 • Up to 5 years post treatment
|
13.3%
87/654 • Number of events 328 • Up to 5 years post treatment
|
|
Investigations
CO diffusing capacity decreased
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Investigations
Cardiac troponin I increased
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Investigations
Cholesterol high
|
1.1%
7/657 • Number of events 41 • Up to 5 years post treatment
|
0.92%
6/654 • Number of events 55 • Up to 5 years post treatment
|
|
Investigations
Creatinine increased
|
6.8%
45/657 • Number of events 190 • Up to 5 years post treatment
|
5.4%
35/654 • Number of events 103 • Up to 5 years post treatment
|
|
Investigations
GGT increased
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Investigations
Hemoglobin increased
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Investigations
INR increased
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 3 • Up to 5 years post treatment
|
|
Investigations
Investigations - Other, specify
|
1.7%
11/657 • Number of events 22 • Up to 5 years post treatment
|
2.1%
14/654 • Number of events 44 • Up to 5 years post treatment
|
|
Investigations
Lipase increased
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Investigations
Lymphocyte count decreased
|
8.5%
56/657 • Number of events 259 • Up to 5 years post treatment
|
10.2%
67/654 • Number of events 300 • Up to 5 years post treatment
|
|
Investigations
Lymphocyte count increased
|
0.30%
2/657 • Number of events 3 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Investigations
Neutrophil count decreased
|
5.0%
33/657 • Number of events 173 • Up to 5 years post treatment
|
2.1%
14/654 • Number of events 66 • Up to 5 years post treatment
|
|
Investigations
Platelet count decreased
|
5.8%
38/657 • Number of events 175 • Up to 5 years post treatment
|
6.3%
41/654 • Number of events 202 • Up to 5 years post treatment
|
|
Investigations
Weight gain
|
2.3%
15/657 • Number of events 93 • Up to 5 years post treatment
|
1.5%
10/654 • Number of events 62 • Up to 5 years post treatment
|
|
Investigations
Weight loss
|
9.1%
60/657 • Number of events 222 • Up to 5 years post treatment
|
11.0%
72/654 • Number of events 295 • Up to 5 years post treatment
|
|
Investigations
White blood cell decreased
|
9.9%
65/657 • Number of events 451 • Up to 5 years post treatment
|
5.5%
36/654 • Number of events 103 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
12.9%
85/657 • Number of events 458 • Up to 5 years post treatment
|
13.1%
86/654 • Number of events 301 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
8/657 • Number of events 9 • Up to 5 years post treatment
|
0.92%
6/654 • Number of events 9 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/657 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 59 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.7%
18/657 • Number of events 30 • Up to 5 years post treatment
|
2.4%
16/654 • Number of events 29 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
51.4%
338/657 • Number of events 2782 • Up to 5 years post treatment
|
49.1%
321/654 • Number of events 2468 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.9%
32/657 • Number of events 80 • Up to 5 years post treatment
|
2.3%
15/654 • Number of events 68 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.46%
3/657 • Number of events 3 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.7%
18/657 • Number of events 35 • Up to 5 years post treatment
|
3.4%
22/654 • Number of events 30 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.1%
7/657 • Number of events 32 • Up to 5 years post treatment
|
0.92%
6/654 • Number of events 8 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.6%
50/657 • Number of events 165 • Up to 5 years post treatment
|
8.9%
58/654 • Number of events 189 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.1%
27/657 • Number of events 53 • Up to 5 years post treatment
|
3.5%
23/654 • Number of events 53 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.1%
7/657 • Number of events 10 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 4 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.1%
86/657 • Number of events 220 • Up to 5 years post treatment
|
27.4%
179/654 • Number of events 469 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.76%
5/657 • Number of events 6 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 11 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.9%
52/657 • Number of events 136 • Up to 5 years post treatment
|
7.2%
47/654 • Number of events 112 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.7%
11/657 • Number of events 18 • Up to 5 years post treatment
|
2.0%
13/654 • Number of events 29 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
1.2%
8/657 • Number of events 10 • Up to 5 years post treatment
|
1.1%
7/654 • Number of events 39 • Up to 5 years post treatment
|
|
Metabolism and nutrition disorders
Obesity
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
44.3%
291/657 • Number of events 2233 • Up to 5 years post treatment
|
34.7%
227/654 • Number of events 1798 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.0%
13/657 • Number of events 30 • Up to 5 years post treatment
|
2.1%
14/654 • Number of events 50 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.4%
75/657 • Number of events 260 • Up to 5 years post treatment
|
9.9%
65/654 • Number of events 333 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
45.7%
300/657 • Number of events 1751 • Up to 5 years post treatment
|
39.9%
261/654 • Number of events 1524 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.15%
1/657 • Number of events 4 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 22 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.61%
4/654 • Number of events 6 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.76%
5/657 • Number of events 6 • Up to 5 years post treatment
|
1.2%
8/654 • Number of events 14 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.4%
42/657 • Number of events 194 • Up to 5 years post treatment
|
7.8%
51/654 • Number of events 231 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.6%
17/657 • Number of events 110 • Up to 5 years post treatment
|
4.6%
30/654 • Number of events 106 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/657 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 16 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
3.2%
21/657 • Number of events 67 • Up to 5 years post treatment
|
3.4%
22/654 • Number of events 110 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.8%
189/657 • Number of events 1102 • Up to 5 years post treatment
|
26.0%
170/654 • Number of events 915 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
13/657 • Number of events 51 • Up to 5 years post treatment
|
1.1%
7/654 • Number of events 30 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.30%
2/657 • Number of events 16 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 15 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.30%
2/657 • Number of events 7 • Up to 5 years post treatment
|
0.61%
4/654 • Number of events 21 • Up to 5 years post treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
49/657 • Number of events 167 • Up to 5 years post treatment
|
6.7%
44/654 • Number of events 220 • Up to 5 years post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
0.46%
3/657 • Number of events 5 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.15%
1/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Nervous system disorders
Akathisia
|
0.46%
3/657 • Number of events 21 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Nervous system disorders
Amnesia
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 3 • Up to 5 years post treatment
|
|
Nervous system disorders
Ataxia
|
0.46%
3/657 • Number of events 6 • Up to 5 years post treatment
|
0.61%
4/654 • Number of events 14 • Up to 5 years post treatment
|
|
Nervous system disorders
Brachial plexopathy
|
0.15%
1/657 • Number of events 2 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Nervous system disorders
Cognitive disturbance
|
1.7%
11/657 • Number of events 81 • Up to 5 years post treatment
|
1.8%
12/654 • Number of events 113 • Up to 5 years post treatment
|
|
Nervous system disorders
Concentration impairment
|
0.76%
5/657 • Number of events 26 • Up to 5 years post treatment
|
1.1%
7/654 • Number of events 55 • Up to 5 years post treatment
|
|
Nervous system disorders
Dizziness
|
9.7%
64/657 • Number of events 237 • Up to 5 years post treatment
|
12.5%
82/654 • Number of events 298 • Up to 5 years post treatment
|
|
Nervous system disorders
Dysarthria
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Nervous system disorders
Dysesthesia
|
0.46%
3/657 • Number of events 26 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Nervous system disorders
Dysgeusia
|
6.4%
42/657 • Number of events 258 • Up to 5 years post treatment
|
5.8%
38/654 • Number of events 161 • Up to 5 years post treatment
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 8 • Up to 5 years post treatment
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Nervous system disorders
Headache
|
24.8%
163/657 • Number of events 1000 • Up to 5 years post treatment
|
26.9%
176/654 • Number of events 826 • Up to 5 years post treatment
|
|
Nervous system disorders
Lethargy
|
0.30%
2/657 • Number of events 3 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 9 • Up to 5 years post treatment
|
|
Nervous system disorders
Memory impairment
|
5.6%
37/657 • Number of events 255 • Up to 5 years post treatment
|
6.0%
39/654 • Number of events 351 • Up to 5 years post treatment
|
|
Nervous system disorders
Movements involuntary
|
0.15%
1/657 • Number of events 3 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 9 • Up to 5 years post treatment
|
|
Nervous system disorders
Muscle weakness left-sided
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 4 • Up to 5 years post treatment
|
|
Nervous system disorders
Muscle weakness right-sided
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
2.0%
13/657 • Number of events 104 • Up to 5 years post treatment
|
2.4%
16/654 • Number of events 88 • Up to 5 years post treatment
|
|
Nervous system disorders
Neuralgia
|
0.15%
1/657 • Number of events 2 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 5 • Up to 5 years post treatment
|
|
Nervous system disorders
Paresthesia
|
1.8%
12/657 • Number of events 44 • Up to 5 years post treatment
|
1.7%
11/654 • Number of events 44 • Up to 5 years post treatment
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.1%
7/657 • Number of events 36 • Up to 5 years post treatment
|
1.2%
8/654 • Number of events 9 • Up to 5 years post treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.5%
43/657 • Number of events 287 • Up to 5 years post treatment
|
4.7%
31/654 • Number of events 123 • Up to 5 years post treatment
|
|
Nervous system disorders
Presyncope
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.61%
4/654 • Number of events 4 • Up to 5 years post treatment
|
|
Nervous system disorders
Seizure
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Nervous system disorders
Somnolence
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Nervous system disorders
Spasticity
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Nervous system disorders
Stroke
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Nervous system disorders
Syncope
|
1.2%
8/657 • Number of events 8 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 10 • Up to 5 years post treatment
|
|
Nervous system disorders
Transient ischemic attacks
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Nervous system disorders
Tremor
|
1.2%
8/657 • Number of events 33 • Up to 5 years post treatment
|
2.0%
13/654 • Number of events 60 • Up to 5 years post treatment
|
|
Nervous system disorders
Vasovagal reaction
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Psychiatric disorders
Agitation
|
0.15%
1/657 • Number of events 2 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 11 • Up to 5 years post treatment
|
|
Psychiatric disorders
Anxiety
|
4.1%
27/657 • Number of events 67 • Up to 5 years post treatment
|
4.9%
32/654 • Number of events 182 • Up to 5 years post treatment
|
|
Psychiatric disorders
Confusion
|
2.3%
15/657 • Number of events 18 • Up to 5 years post treatment
|
2.8%
18/654 • Number of events 51 • Up to 5 years post treatment
|
|
Psychiatric disorders
Delirium
|
0.15%
1/657 • Number of events 3 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Psychiatric disorders
Depression
|
5.5%
36/657 • Number of events 155 • Up to 5 years post treatment
|
6.7%
44/654 • Number of events 218 • Up to 5 years post treatment
|
|
Psychiatric disorders
Hallucinations
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 25 • Up to 5 years post treatment
|
|
Psychiatric disorders
Insomnia
|
32.0%
210/657 • Number of events 1574 • Up to 5 years post treatment
|
31.0%
203/654 • Number of events 1503 • Up to 5 years post treatment
|
|
Psychiatric disorders
Irritability
|
0.61%
4/657 • Number of events 8 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Psychiatric disorders
Libido decreased
|
0.30%
2/657 • Number of events 10 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 3 • Up to 5 years post treatment
|
|
Psychiatric disorders
Personality change
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.46%
3/657 • Number of events 9 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 9 • Up to 5 years post treatment
|
|
Psychiatric disorders
Restlessness
|
0.15%
1/657 • Number of events 10 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 33 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Bladder spasm
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.1%
7/657 • Number of events 45 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 30 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Hematuria
|
4.7%
31/657 • Number of events 69 • Up to 5 years post treatment
|
4.7%
31/654 • Number of events 64 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/657 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 14 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
3.2%
21/657 • Number of events 66 • Up to 5 years post treatment
|
2.6%
17/654 • Number of events 51 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Renal calculi
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 9 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Renal colic
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Urinary frequency
|
7.2%
47/657 • Number of events 243 • Up to 5 years post treatment
|
6.7%
44/654 • Number of events 266 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Urinary incontinence
|
4.0%
26/657 • Number of events 141 • Up to 5 years post treatment
|
3.5%
23/654 • Number of events 136 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Urinary retention
|
1.1%
7/657 • Number of events 16 • Up to 5 years post treatment
|
2.0%
13/654 • Number of events 28 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.46%
3/657 • Number of events 9 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Urinary tract pain
|
0.76%
5/657 • Number of events 12 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Urinary urgency
|
1.8%
12/657 • Number of events 60 • Up to 5 years post treatment
|
1.2%
8/654 • Number of events 27 • Up to 5 years post treatment
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 5 • Up to 5 years post treatment
|
|
Reproductive system and breast disorders
Breast pain
|
0.91%
6/657 • Number of events 28 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.2%
21/657 • Number of events 318 • Up to 5 years post treatment
|
2.0%
13/654 • Number of events 184 • Up to 5 years post treatment
|
|
Reproductive system and breast disorders
Genital edema
|
0.15%
1/657 • Number of events 3 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Reproductive system and breast disorders
Gynecomastia
|
3.7%
24/657 • Number of events 243 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 57 • Up to 5 years post treatment
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.91%
6/657 • Number of events 9 • Up to 5 years post treatment
|
0.92%
6/654 • Number of events 33 • Up to 5 years post treatment
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 4 • Up to 5 years post treatment
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
0.30%
2/657 • Number of events 3 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 2 • Up to 5 years post treatment
|
|
Reproductive system and breast disorders
Testicular disorder
|
0.15%
1/657 • Number of events 2 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 3 • Up to 5 years post treatment
|
|
Reproductive system and breast disorders
Testicular pain
|
0.61%
4/657 • Number of events 13 • Up to 5 years post treatment
|
0.92%
6/654 • Number of events 61 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.2%
8/657 • Number of events 77 • Up to 5 years post treatment
|
2.4%
16/654 • Number of events 108 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.1%
191/657 • Number of events 899 • Up to 5 years post treatment
|
31.5%
206/654 • Number of events 924 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.8%
189/657 • Number of events 1380 • Up to 5 years post treatment
|
30.7%
201/654 • Number of events 1391 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
7/657 • Number of events 12 • Up to 5 years post treatment
|
0.76%
5/654 • Number of events 8 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
1.2%
8/657 • Number of events 33 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 3 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/657 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 3 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.1%
14/657 • Number of events 24 • Up to 5 years post treatment
|
1.4%
9/654 • Number of events 48 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.46%
3/657 • Number of events 3 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 4 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.61%
4/657 • Number of events 5 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 4 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 4 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.46%
3/657 • Number of events 17 • Up to 5 years post treatment
|
0.92%
6/654 • Number of events 7 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 2 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.61%
4/657 • Number of events 18 • Up to 5 years post treatment
|
0.61%
4/654 • Number of events 4 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.8%
12/657 • Number of events 17 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 3 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 4 • Up to 5 years post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.61%
4/657 • Number of events 6 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 3 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.46%
3/657 • Number of events 9 • Up to 5 years post treatment
|
1.8%
12/654 • Number of events 119 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.8%
25/657 • Number of events 146 • Up to 5 years post treatment
|
2.4%
16/654 • Number of events 107 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 3 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.2%
8/657 • Number of events 52 • Up to 5 years post treatment
|
0.92%
6/654 • Number of events 21 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.30%
2/657 • Number of events 29 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.30%
2/657 • Number of events 3 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.46%
3/657 • Number of events 14 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 8 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
10/657 • Number of events 46 • Up to 5 years post treatment
|
2.1%
14/654 • Number of events 35 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/657 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 4 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.46%
3/657 • Number of events 11 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 4 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.7%
18/657 • Number of events 62 • Up to 5 years post treatment
|
3.4%
22/654 • Number of events 44 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
3.7%
24/657 • Number of events 98 • Up to 5 years post treatment
|
4.0%
26/654 • Number of events 80 • Up to 5 years post treatment
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.15%
1/657 • Number of events 7 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 8 • Up to 5 years post treatment
|
|
Social circumstances
Social circumstances - Other, specify
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
0.46%
3/657 • Number of events 4 • Up to 5 years post treatment
|
0.46%
3/654 • Number of events 4 • Up to 5 years post treatment
|
|
Vascular disorders
Flushing
|
0.61%
4/657 • Number of events 34 • Up to 5 years post treatment
|
1.5%
10/654 • Number of events 56 • Up to 5 years post treatment
|
|
Vascular disorders
Hematoma
|
0.76%
5/657 • Number of events 5 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Vascular disorders
Hot flashes
|
63.3%
416/657 • Number of events 5649 • Up to 5 years post treatment
|
67.0%
438/654 • Number of events 5781 • Up to 5 years post treatment
|
|
Vascular disorders
Hypertension
|
62.9%
413/657 • Number of events 5471 • Up to 5 years post treatment
|
63.6%
416/654 • Number of events 5628 • Up to 5 years post treatment
|
|
Vascular disorders
Hypotension
|
1.7%
11/657 • Number of events 16 • Up to 5 years post treatment
|
1.5%
10/654 • Number of events 11 • Up to 5 years post treatment
|
|
Vascular disorders
Lymph leakage
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Vascular disorders
Lymphedema
|
0.00%
0/657 • Up to 5 years post treatment
|
0.15%
1/654 • Number of events 1 • Up to 5 years post treatment
|
|
Vascular disorders
Peripheral ischemia
|
0.15%
1/657 • Number of events 1 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
|
Vascular disorders
Thromboembolic event
|
0.30%
2/657 • Number of events 2 • Up to 5 years post treatment
|
0.61%
4/654 • Number of events 5 • Up to 5 years post treatment
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.76%
5/657 • Number of events 15 • Up to 5 years post treatment
|
0.31%
2/654 • Number of events 31 • Up to 5 years post treatment
|
|
Vascular disorders
Vasculitis
|
0.15%
1/657 • Number of events 15 • Up to 5 years post treatment
|
0.00%
0/654 • Up to 5 years post treatment
|
Additional Information
Michael J. Morris, MD
Memorial Sloan-Kettering Cancer Center
Phone: 646-422-4469
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place