Trial Outcomes & Findings for Chemotherapy After Prostatectomy (CAP) For High Risk Prostate Carcinoma (NCT NCT00132301)
NCT ID: NCT00132301
Last Updated: 2018-06-25
Results Overview
The primary objective of this study is to determine whether adding early chemotherapy based on docetaxel plus prednisone compared to standard of care alone reduces disease progression as evidenced by detectable PSA in high risk patients with prostate cancer who have undergone radical prostatectomy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
298 participants
Primary outcome timeframe
Up to 100 months (centralized follow-up)
Results posted on
2018-06-25
Participant Flow
Participant milestones
| Measure |
Arm 1: Chemotherapy Agent and Prednisone
Chemotherapy after radical prostatectomy
Docetaxel: Chemotherapy agent
Prednisone: steroid in combination with chemotherapy agent
|
Arm 2: Standard of Care
Treatment by Standard of Care
|
|---|---|---|
|
Overall Study
STARTED
|
141
|
157
|
|
Overall Study
COMPLETED
|
121
|
144
|
|
Overall Study
NOT COMPLETED
|
20
|
13
|
Reasons for withdrawal
| Measure |
Arm 1: Chemotherapy Agent and Prednisone
Chemotherapy after radical prostatectomy
Docetaxel: Chemotherapy agent
Prednisone: steroid in combination with chemotherapy agent
|
Arm 2: Standard of Care
Treatment by Standard of Care
|
|---|---|---|
|
Overall Study
Death
|
7
|
6
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
|
Overall Study
Other
|
1
|
1
|
|
Overall Study
Excluded by Data Monitoring Committee
|
1
|
0
|
Baseline Characteristics
Chemotherapy After Prostatectomy (CAP) For High Risk Prostate Carcinoma
Baseline characteristics by cohort
| Measure |
Arm 1: Chemotherapy Agent and Prednisone
n=140 Participants
Chemotherapy after radical prostatectomy
Docetaxel: Chemotherapy agent
Prednisone: steroid in combination with chemotherapy agent
|
Arm 2: Standard of Care
n=157 Participants
Treatment by Standard of care
|
Total
n=297 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
106 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
221 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
62.27 years
STANDARD_DEVIATION 5.6 • 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
|
140 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
123 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
94 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
207 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
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
140 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
|
BMI
BMI < 25
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
BMI
BMI 25 to < 30
|
60 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
BMI
BMI >= 30
|
51 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Pre Biopsy PSA (ng/ml)
< 10
|
91 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Pre Biopsy PSA (ng/ml)
10 to < 20
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Pre Biopsy PSA (ng/ml)
>= 20
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Pre Biopsy PSA (ng/ml)
Unknown or not reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Pre Prostatectomy PSA (ng/ml)
< 10
|
85 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Pre Prostatectomy PSA (ng/ml)
10 to < 20
|
38 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Pre Prostatectomy PSA (ng/ml)
>=20
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Biopsy Gleason Score
<= 7
|
97 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Biopsy Gleason Score
8 to 10
|
43 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Prostatectomy Gleason Score
<= 7
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Prostatectomy Gleason Score
7: 3+4
|
52 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Prostatectomy Gleason Score
7: 4+3
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Prostatectomy Gleason Score
8-10
|
46 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Clinical Stage
cT1
|
67 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Clinical Stage
cT2a
|
36 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Clinical Stage
cT2b
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Clinical Stage
cT2c
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Clinical Stage
unknown or not reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Pathology Stage
T2a, T2b, T2c
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Pathology Stage
T3a
|
81 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Pathology Stage
> T3b
|
48 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 100 months (centralized follow-up)Population: One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
The primary objective of this study is to determine whether adding early chemotherapy based on docetaxel plus prednisone compared to standard of care alone reduces disease progression as evidenced by detectable PSA in high risk patients with prostate cancer who have undergone radical prostatectomy.
Outcome measures
| Measure |
Arm 1: Docetaxel and Prednisone
n=140 Participants
Chemotherapy after radical prostatectomy
Docetaxel: Chemotherapy agent
Prednisone: steroid in combination with chemotherapy agent
|
Arm 2: Standard of Care
n=157 Participants
Treatment by standard of care
|
|---|---|---|
|
Number of Participants With Progression-Free Survival
|
66 Participants
|
84 Participants
|
Adverse Events
Arm 1: Chemotherapy Agent
Serious events: 47 serious events
Other events: 79 other events
Deaths: 0 deaths
Arm 2: Standard of Care
Serious events: 50 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Chemotherapy Agent
n=140 participants at risk
Chemotherapy after radical prostatectomy
Docetaxel: Chemotherapy agent
Prednisone: steroid in combination with chemotherapy agent
|
Arm 2: Standard of Care
n=157 participants at risk
Treatment by Standard of Care
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Cardiac disorders
Cornary artery disease
|
2.1%
3/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
1.3%
2/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Cardiac disorders
Myocardial infarction
|
2.1%
3/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Cardiac disorders
Sinus bradycardia
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Gastrointestinal disorders
Spigelian hernia
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Gastrointestinal disorders
Anal fistula
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Gastrointestinal disorders
Colitis
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
General disorders
Adverse drug reaction
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
General disorders
Chest pain
|
1.4%
2/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
1.9%
3/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
General disorders
Death
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
General disorders
Pyrexia
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.4%
2/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Infections and infestations
Cellulitis
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Infections and infestations
Diverticulitis
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Infections and infestations
Influenza
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Infections and infestations
Pneumonia
|
3.6%
5/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
1.3%
2/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
1.9%
3/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Infections and infestations
Clostridial infection
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Infections and infestations
Endocarditis
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Infections and infestations
Endocarditis bacterial
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Infections and infestations
Oral infection
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Infections and infestations
Septic shock
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Infections and infestations
Staphylococcal infection
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Injury, poisoning and procedural complications
Fall
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
2.1%
3/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
1.3%
2/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Injury, poisoning and procedural complications
Accident at work
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Injury, poisoning and procedural complications
Traumatic arthritis
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Investigations
Biopsy bone
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Metabolism and nutrition disorders
Hyperglcaemia
|
1.4%
2/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
1.3%
2/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningeal neoplasm
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Nervous system disorders
Cartoid artery stenosis
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Nervous system disorders
Cerebral vascular accident
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
1.3%
2/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Nervous system disorders
Hemmorhage intracranial
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Nervous system disorders
Mayasthenia gravis
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Nervous system disorders
Presyncope
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Nervous system disorders
Vascular dementia
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Psychiatric disorders
Drug abuse
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Psychiatric disorders
Achohol withdrawal syndrome
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Psychiatric disorders
Biopolar disorder
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.1%
3/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
3.2%
5/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.4%
2/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
1.9%
3/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Reproductive system and breast disorders
Organic erectile dysfunction
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
1.3%
2/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obtructive pulonary disease
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulomary embolism
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Skin and subcutaneous tissue disorders
Dry gangrene
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Skin and subcutaneous tissue disorders
Vasculitic rash
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Surgical and medical procedures
Aortic bypass
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Surgical and medical procedures
Lipoma excision
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Surgical and medical procedures
Chemotherapy
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
1.4%
2/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Vascular disorders
Arterial Thrombosis
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Vascular disorders
Iliac artery occlusion
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
Other adverse events
| Measure |
Arm 1: Chemotherapy Agent
n=140 participants at risk
Chemotherapy after radical prostatectomy
Docetaxel: Chemotherapy agent
Prednisone: steroid in combination with chemotherapy agent
|
Arm 2: Standard of Care
n=157 participants at risk
Treatment by Standard of Care
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
39.3%
55/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
General disorders
Asthenia
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
General disorders
Fatigue
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Infections and infestations
Tooth abscess
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Investigations
Blood glucose increased
|
2.1%
3/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Investigations
White blood cell count decreased
|
2.1%
3/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
17.9%
25/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Nervous system disorders
Dizziness
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.4%
2/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Nervous system disorders
Syncope
|
2.1%
3/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Psychiatric disorders
Anxiety
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Skin and subcutaneous tissue disorders
Cold Sweat
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Surgical and medical procedures
Carpal tunnel decompression
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Surgical and medical procedures
Hernia repair
|
0.00%
0/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.64%
1/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.71%
1/140
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
0.00%
0/157
One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place